Associate Director Regulatory Liaison - Oncology
$129k - $203.1kFull-time
Merck
Job Description The Associate Director, Regulatory Affairs, supports products in the Oncology therapeutic area as part of a regulatory team.- The individual will have excellent communication and collaboration skills and will work closely with a global regulatory lead(s) to help develop and implement a global strategy for registration and/or maintenance of products.- Responsibilities may encompass all aspects of planning and implementation of a global regulatory strategy and regulatory submissions including assisting in preparing submissions, protocol review, and conducting research on regulatory guidance's or competitive intelligence.- The individual will have responsibility for driving results for his/her assigned projects through application of regulatory science and strong communication and analytical skills.--- Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. Primary Responsibilities:
Education Minimum Requirements:
Preferred Experience and Skills:
Cross-Functional Teamwork, Global Regulatory, Investigational New Drug, Label Development, Life Cycle Planning, Pharmaceutical Industry, Product Registrations, Regulatory Communications, Regulatory Documents, Regulatory Experience, Regulatory Filings, Regulatory Reporting, Regulatory Strategies, Regulatory Submissions, Stakeholder Engagement Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement• We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is
$129,000.00 - $203,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at . You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: -We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: -We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully-
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. -No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.- Employee Status:
Regular Relocation:
No relocation VISA Sponsorship:
No Travel Requirements:
10% Flexible Work Arrangements:
Hybrid Shift:
Not Indicated Valid Driving License:
No Hazardous Material(s):
n/a Job Posting End Date:
10/17/2026
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R419382
- Assisting in Regulatory Agency communications and submissions, including marketing applications, investigational new drug (IND) applications, pediatric plans and annual or other periodic reports. The individual may also assist or take the lead in tracking, authoring, shepherding and/or review of responses to Agency requests.
- Implementing strategy to develop Agency background packages and documents associated with regulatory submissions for marketing applications.
- Communicating with Agencies and attending Agency meetings as needed to assist the global regulatory lead.
- Participating as an active member on the global regulatory team.- Individual will attend cross-functional meetings as required, in collaboration with, and to assist the global regulatory lead.
- Conducting research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy.- Assist the global regulatory lead in authoring of regulatory strategy documents.
- Collaborating and communicating regulatory strategy as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and Control (CMC) as well as other functional areas (e.g., clinical research, non-clinical safety assessment).
- Support maintenance (e.g., quality compliance and life cycle management) of oncology programs.
- Support of global regulatory lead in label development.
- Assisting with process improvement initiative.
- Performing regulatory administrative activities, as needed.
Education Minimum Requirements:
- Bachelor's Degree, with at least 5 years of relevant experience in the pharmaceutical industry.
- Master's Degree with at least 2 years of relevant experience in pharmaceutical industry.
- M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline with relevant experience.
- Experience in drug development
- Prior regulatory experience interacting with a major regulatory agency
Excellent communication skills (both oral and written). - Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects.
- Flexibility required.
- Strong scientific and analytical skills with attention to detail.
Preferred Experience and Skills:
- Experience with oncology products is highly preferred
Cross-Functional Teamwork, Global Regulatory, Investigational New Drug, Label Development, Life Cycle Planning, Pharmaceutical Industry, Product Registrations, Regulatory Communications, Regulatory Documents, Regulatory Experience, Regulatory Filings, Regulatory Reporting, Regulatory Strategies, Regulatory Submissions, Stakeholder Engagement Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement• We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is
$129,000.00 - $203,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at . You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: -We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: -We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully-
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. -No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.- Employee Status:
Regular Relocation:
No relocation VISA Sponsorship:
No Travel Requirements:
10% Flexible Work Arrangements:
Hybrid Shift:
Not Indicated Valid Driving License:
No Hazardous Material(s):
n/a Job Posting End Date:
10/17/2026
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R419382
Vacancy posted 6 days ago
Similar jobs that could be interesting for youBased on the Associate Director Regulatory Liaison - Oncology in Boston, MA vacancy
$129k - $203.1k
...Associate Director in Regulatory Affairs supporting oncology products at a pharmaceutical company. The role involves developing and implementing global regulatory strategies, managing agency submissions, and collaborating across functional teams to advance product registrations...Suggested$154.4k - $242.55k
...OneOncology vision, we are advancing a rapidly growing oncology portfolio with potentially first-in-class and best-in-class... ...a lasting impact on patients worldwide.Join Takeda as Associate Director, Global Regulatory Lead Oncology where you will be part of the global...SuggestedMinimum wageLocal areaRemote workWorldwideTakeda
Boston, MA2 days ago- ...Role: Associate Director, Global Regulatory Project Management and Strategic Planning in Oncology at Takeda, remotely based. Responsibilities partner with the Global Regulatory Lead to develop and execute global regulatory project plans lead cross-functional submission...SuggestedRemote work
$154.4k - $242.55k
...innovation‑driven company that will inspire you and empower you to shine? Join us as an Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology TAU within our Global Regulatory Affairs organization, based remotely. Partners with the...SuggestedMinimum wageFull timeLocal areaRemote workWorldwide- ## Associate Director, Regulatory Affairs CMCApplyremote type: Site Basedlocations: South Boston, MAtime type: Full timeposted on: Posted Todayjob... ...across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues...SuggestedContract workRemote work
$143k - $233k
..., this position will play a key role in regulatory strategy development and execution of assigned... ...teams and act as the regulatory CMC liaison between CMC/PD, regulatory affairs and/... ...therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array...Relay Therapeutics
Somerville, MA21 hours ago$166.4k - $249.6k
Job DescriptionGeneral Summary:The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and commercial products focusing on biologics. This role is accountable for authoring, reviewing, and...Full timeSummer workRemote workFlexible hours2 days per weekVertex Pharmaceuticals
Boston, MA2 days ago$231.9k - $365k
Job DescriptionOur Regulatory Affairs team in General Medicine advances medical innovation... ...Position Description:The Executive Director, Regulatory Affairs Liaison reports to the Vice President (VP),... ..., Global Regulatory, Leadership, Oncology Drug Development, Ophthalmology,...Full timeFor contractorsLocal areaWorldwideFlexible hoursMerck Sharp & Dohme (MSD)
Boston, MA3 days ago$170.9k - $231.3k
OverviewThe Associate Director of Regulatory Affairs Strategy will work on assigned programs with the respective Global Regulatory Portfolio Lead,... ...questions with strict adherence to deadlines.Serve as a liaison within internal departments at Alnylam, with CROs and with...Full timeTemporary workLocal areaWorldwideFlexible hours2 days per weekAlnylam Pharmaceuticals
Cambridge, MA1 day ago$142.5k - $256.5k
...engine fueling a high-growth organization that is radically changing the biotech industry.Reporting to the Director, Regulatory Information Management (RIM), the Associate Director, Regulatory Data Management & Intelligence is responsible for defining and advancing Moderna’...Permanent employmentFull timeFor contractorsWork at officeWork from homeModerna Therapeutics
Somerville, MA21 hours ago$154.4k - $242.55k
...the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of...Minimum wageLocal areaRemote workWorldwideTakeda
Boston, MA3 days ago$150k - $214k
The Opportunity Reporting to the Executive Director, Head of Regulatory Project Management, you will support the planning, coordination, and execution... ...small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental...Work at officeRelay Therapeutics
Cambridge, MA1 day ago$170.9k - $231.3k
OverviewThe Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementing global CMC regulatory strategies for development-stage programs. This role will play a critical part in shaping regulatory strategies for emerging therapeutic...Full timeTemporary workWork at officeLocal areaFlexible hoursAlnylam Pharmaceuticals
Somerville, MA1 day ago$154.4k - $242.55k
...strategic and tactical guidance to teams for the delivery of global regulatory strategies to support development and commercialization of... ...and reviewing guidance comments and supporting trade association working groups.Education & Competencies (Technical and Behavioral...Minimum wageLocal areaRemote workTakeda
Boston, MA3 days ago$196.7k - $353.4k
The Role:Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology programs to be based in its Cambridge headquarters. This is a newly created role intended for a forward looking, creative regulatory strategist able to anticipate and address...Permanent employmentFull timeWork at officeWork from homeModerna Therapeutics
Cambridge, MA21 hours ago$154.4k - $242.55k
...that will inspire you and empower you to shine? Join us as an Associate Director, Tumor Genomics and Targeted Credentialingin our Cambridge... ...Credentialing will be a key scientific and delivery leader within the Oncology Computational Biology Delivery team in the Computational...Minimum wageWork at officeLocal areaRemote workTakeda
Somerville, MA2 days ago$169.4k - $266.2k
...information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:As a member of Takeda Oncology, your work will contribute to our bold, inspiring vision: We aspire to cure cancer. Here, you'll build a career grounded in...Minimum wageLocal areaRemote workTakeda
Cambridge, MA14 hours ago- ...Relay Therapeutics seeks an experienced CMC regulatory professional to lead chemistry, manufacturing, and control strategy development and execution for investigational and commercial pharmaceutical programs. This role requires independent management of global regulatory...
Relay Therapeutics
Cambridge, MA5 days ago $152.6k - $283.4k
...Cambridge, MA, USAAbout the RoleWe are seeking an accomplished Associate Director to join our discovery organization and lead scientific... ...industry experience in ADC discovery, targeted therapeutics, or oncology drug discoveryExtensive expertise in ADC payloads, including...Full timeNovartis
Cambridge, MA21 hours ago$160k - $190k
...focus of every strategic decision.Our pipeline is promising in Oncology and Neurology, and following the acquisition of Sevasemten... ...for our first launch in Neurology.Role Summary The Associate Director, Neurology Analytics will report into the Senior Director of...Temporary workWork at officeFlexible hours2 days per week3 days per weekLes Laboratoires Servier
Boston, MA3 days ago$166.4k - $249.6k
...Associate Director of Regulatory CMC for biologics who will lead global regulatory strategy, author and review CMC submissions for investigational and commercial products, and serve as the primary Health Authority interface. The role emphasizes integration of AI and digital...Vertex Pharmaceuticals
Boston, MA5 days ago$176k - $208k
Associate Director, Medical Portfolio Management (Neurology)About Servier Servier Pharmaceuticals is an independent, commercial-stage biopharmaceutical... ...serious diseases with high unmet need, particularly in rare oncology and neurology.Our ambition is clear: to build a leading U.S....Temporary workRemote workFlexible hoursLes Laboratoires Servier
Boston, MA1 day ago- ...focus of the PDT R&D organization: Translational Pharmaceutical Sciences and Precision Medicine The Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU) is a key role in Global Labeling and works under the direction...
- ...in the US! This is a remote role. Oncology experience is required for this role... ...preferred! The Local Study Associate Director (LSAD) leads Local Study Team(s) (... ...activities associated with audits and regulatory inspections in liaison with Clinical Quality Associate...Local areaRemote workFlexible hours
PAREXEL
Boston, MA3 days ago - ...Representing statistical issues in regulatory agency meetings. Leading... ...the company in professional associations, conferences, and publications. As an Associate Director, responsible for mentoring... ...Preferred: Hematology, IO, non-oncology, Multiple Myeloma experience...Full time
Regeneron
Cambridge, MA1 day ago - ...Rapport Therapeutics seeks an Associate Director of Regulatory Strategy to develop and execute regulatory pathways for a small-molecule neuromedicine pipeline. This Boston-based role involves cross-functional collaboration, regulatory authority engagement, and strategic...
Rapport Therapeutics
Boston, MA5 days ago - ...Hybrid, 2-3 days/week onsiteReports to: Chief Medical OfficerPosition SummaryThis individual will lead regulatory strategy and execution for growing clinical-stage oncology pipeline. The role will work closely with Clinical Development, Clinical Operations, CMC, Quality,...2 days per week3 days per week
Planet Pharma
Somerville, MA4 days ago $194.4k - $291.6k
...targets in cancer.This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and... ...in the Fenway area of Boston, Massachusetts.SummaryThe Medical Director/Medical Reviewer, Pharmacovigilance will be responsible to...Tango Therapeutics
Boston, MA4 days ago$158.6k - $285.5k
The Role This role will support Oncology Therapeutic programs, specifically supporting the Clinical Study Lead in the development, execution... ...studies to support both internal governance decisions and regulatory submissions.Here’s What You’ll DoBroadly stated, in...Permanent employmentFull timeWork at officeWork from homeModerna Therapeutics
Somerville, MA3 days ago$144k - $216k
...collaborate in cross-functional teams spanning AstraZeneca’s key Oncology foci of hematology, cell therapy, antibody-drug conjugates,... ..., and adoption Partner with clinical development, biometrics, regulatory, and study teams to develop and then validate novel AI solutions...Full timeTemporary workWork experience placementAstraZeneca
Cambridge, MA2 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Associate Director Regulatory Liaison - Oncology. Be the first to apply!
Related searches
- associate director contracts Boston, MA
- associate manager brand marketing Boston, MA
- associate director engineering Boston, MA
- remote associate product manager Boston, MA
- associate director compliance Boston, MA
- associate manager Boston, MA
- associate media manager Boston, MA
- associate director biostatistics Boston, MA
- associate medical director Boston, MA
- associate business manager Boston, MA