Senior Regulatory Affairs Manager
Katalyst Healthcares and Life Sciences
- The Global Regulatory Affairs (GRA) is responsible for obtaining approval for new products and ensuring that approval is maintained throughout the product lifecycle.
- GRA serves as the interface between the regulatory authorities and the program teams aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product.
- It is the responsibility of GRA to keep abreast of current legislation, policies, guidelines and other regulatory intelligence.
- The RA department plays an important role in giving advice to the program teams on how best to interpret the regulatory legislation and guidelines.
- The Regulatory Affairs Nonclinical / Clinical team plays a key role in defining the regulatory strategy and pathway for a product by leading the development and execution of the nonclinical / clinical regulatory strategy and plan in alignment the overall clinical development plan.
- This team will take a lead role in planning and developing relevant sections of regulatory filings required for product approvals.
- In addition, this team will lead planning, coordinating and engaging directly with Health Authorities before, during and after regulatory approval milestones.
- The Reg Nonclinical / Clinical Associate Director will lead, conceive, communicate and execute upon the global clinical and nonclinical regulatory strategies throughout a program's lifecycle that are in alignment with corporate goals and timelines.
- This includes formulating the global Nonclinical / Clinical strategy for the Global Regulatory Plan, acting as the key liaison with Health Authorities and leading the preparation of Nonclinical / Clinical documentation to support global regulatory filings, including post-approval activities and life-cycle expansion opportunities.
- The Company's Associate Director is viewed as a subject matter expert in the functional area involved in developing, modifying and executing on product strategies and have a function and may have a companywide impact.
- The AD will typically collaborate, influence and negotiate with senior Nonclinical / Clinical leaders on product strategies and actions leveraging their advanced Nonclinical / Clinical knowledge.
- Lead the development, integration, execution and maintenance of the global nonclinical and clinical regulatory strategy for the Global Regulatory Plan (GRP) throughout the product lifecycle.
- Ensure strategic alignment with the Clinical Development Plan (CDP) and nonclinical development plan with input from clinical and nonclinical Subject Matter Experts (SMEs), respectively, and regional regulatory leads.
- Provide strategic insight to the GRT regarding product development, and serve as Regulatory contributor to partner teams (eg, study execution teams, clinical development team etc.) as appropriate
- In collaboration with regional regulatory representatives, ensure that feedback from global Health Authorities is incorporated into the global nonclinical and clinical development strategy.
- Incorporate RA INTL guidance on development programs (i.e., INTL requirements or policies that may impact clinical development and commercialization).
- Develop global pediatric strategy; collaborate with regional leads on the content for regional pediatric plans (e.g., PIP); ensure global pediatric strategy is reflected in the Global Regulatory Plan; ensure any changes to CDP or Nonclinical development plans are assessed by regional leads for impact to pediatric plan agreements with Health Authorities.
- Lead/support strategy for life-cycle expansion opportunities
- Clinical and Nonclinical Development Plan Advancement
- ct as a key contributor to the Clinical and Nonclinical Development Plans and ensure that they incorporate consideration of current global health authority precedents and regulatory guidance.
- Provide both proactive and reactive strategic input and regulatory expertise in the design and conduct of clinical and nonclinical studies
- Contribute critically to the scientific interpretation and integration of clinical and nonclinical study results.
- Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience
- 6 + year experience with PhD; 8+ years with Masters or bachelor's degrees
- Nonclinical / Clinical Regulatory Affairs experience preferred
Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Affairs Manager in Boston, MA vacancy
- ...Regulatory Affairs Nonclinical / Clinical Associate Director The Global Regulatory Affairs (GRA) is responsible for obtaining approval for... ...AD will typically collaborate, influence and negotiate with senior Nonclinical / Clinical leaders on product strategies and actions...Senior
Katalyst HealthCares & Life Sciences
Boston, MA4 days ago - ...A medical device company in Cambridge, MA, is seeking a Regulatory Affairs professional to lead regulatory strategies for Class II medical devices. Responsibilities include managing FDA submissions, ensuring regulatory compliance throughout product development, and collaborating...Senior
Medella Life
Cambridge, MA9 hours ago - Dormont Manufacturing Co in Boston seeks a Director for US Advertising and Promotional Compliance. This role will oversee regulatory content for promotional materials and liaise with the FDA. Responsibilities include leading strategic initiatives, reviewing promotional...Senior
- ...Officer to oversee the integrity of the compliance program at a leading U.S.-based asset management firm. This senior role involves implementing compliance frameworks, managing regulatory adherence, and mitigating compliance risks. The ideal candidate will have over 10...SeniorFlexible hours
- ...Senior Vice President, Legal and Chief Compliance Officer (CCO) About the Company Nationally recognized healthcare services organization... ...an enterprise compliance program, translating legal and regulatory requirements into operational guidance, and leading the legal...Senior
- ...Senior Regulatory Affairs Manager- REMOTE I'm looking for a senior manager, regulatory affairs to lead our growing, dynamic team through global phase 3 clinical trials of a certain product and support other clinical studies. This role includes driving global submission...SeniorFull timeRemote work
Barrington James
Boston, MA2 days ago - ...Inc. is seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing & Controls. The successful... ...will lead the development of regulatory CMC strategies and manage submissions critical to product lifecycle. Applicants must hold...Senior
Initial Therapeutics, Inc.
Boston, MA2 days ago - ...Bicara Therapeutics is seeking a strategic and experienced Senior Director of Regulatory Affairs to lead and execute US regulatory strategy for our... ...—from IND through BLA submission and approval. You will manage a small team of Regulatory Affairs professionals, providing...SeniorWork at officeLocal area3 days per week
Bicara Therapeutics
Boston, MA9 hours ago $211.85k - $317.78k
...Job Title: Senior Director, Global Regulatory Strategy - Early Development & Business Development Location: Boston, MA At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately...SeniorHourly payTemporary workWork at office3 days per weekAstraZeneca
Boston, MA1 day ago- ...Regulatory Manager The Regulatory Manager provides regulatory strategy and development guidance... ...as representative of Global Regulatory Affairs at project team meetings with both... ...Regulatory experience required for the Senior Manager Regulatory level. Candidates...SeniorFlexible hoursNight shift
$146.96k - $210.1k
...Provides critical support in developing global regulatory strategy, planning and execution of... ...prescription drug submissions and manages lifecycle activities for all assigned projects... ...with 2 years’ experience in regulatory affairs or related areas (e.g., clinical...SeniorTemporary workWork at officeLocal areaFlexible hours- A leading cancer research organization located in Brookline is seeking a Regulatory Compliance Director to develop and oversee a comprehensive compliance program. The ideal candidate will have significant experience in regulatory healthcare compliance and leadership. This...Senior
- Join EY as a Senior Manager in the Life Sciences Regulatory Submissions practice, located in Boston. You will drive growth and be pivotal in establishing EY as a leader in the Regulatory Compliance sector. The role involves leading teams, building client relationships,...Senior
- Scorpion Therapeutics is seeking a Regulatory Strategy Lead in Boston, MA. This role involves developing regulatory strategies focusing on Human Factors for devices and drug-device combinations. The ideal candidate will have over 10 years of regulatory CMC experience and...Senior
$196.7k - $353.4k
...seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader... ...to the company ~ Demonstrated competence in employee management and development ~ Knowledge of and broad experience with regulatory...SeniorPermanent employmentWork at officeWork from homeModerna
Cambridge, MA5 days ago$270k - $330k
...The Senior Director, Global Regulatory Affairs, Oncology is accountable for providing regulatory strategic leadership to assigned program(s) and implementing... ...are proactively proposed for project team and senior management decision making.Be accountable for the flawless...SeniorTemporary workLocal areaWorldwideFlexible hoursIPSEN
Cambridge, MA9 hours ago- A leading biotechnology company in Boston is seeking a Regulatory Strategy Senior Director to oversee global regulatory strategies for development... ..., ensuring cohesive integration of regulatory ideas, and managing cross-functional teams. Candidates need deep knowledge of...Senior3 days per week
- Vertex Pharmaceuticals Inc (US) is seeking a Regulatory Strategy Senior Director to lead the development of regulatory strategies for complex projects... ...or Chemistry, with significant experience in regulatory affairs and proven leadership in a matrix environment. Vertex...Senior
$140k - $155k
CRISPR Therapeutics in Boston is seeking a Senior Manager, Drug Safety to lead compliance oversight and end-to-end case management. The role... ...'s degree, 10+ years in pharmacovigilance, and strong regulatory understanding. The position offers a salary range of $140,000...Senior$208.2k - $327.14k
A leading global R&D organization is seeking a Senior Director, Global Regulatory Lead - Oncology. This role involves leading global regulatory strategy and engaging with cross-functional teams to ensure the success of innovative oncology therapies. The successful candidate...Senior- Bicara Therapeutics is seeking a Senior Director of Regulatory Affairs in Boston. This role will lead US regulatory strategy for the biologics pipeline, overseeing regulatory submissions and health authority interactions. The ideal candidate will have 10-12 years of experience...SeniorWork at office3 days per week
- Takeda is seeking a Senior Director, Global Regulatory Lead for Oncology in Boston, MA. This role involves leading global regulatory strategy for complex oncology projects, with responsibilities that include overseeing FDA submissions and ensuring compliance with regulatory...Senior
- ...is seeking a seasoned scientific leader for a senior role in Nonclinical Safety Evaluation in... ...strategic leadership in Toxicology and Pathology, managing teams, and developing nonclinical safety strategies to support regulatory submissions across therapeutic areas....Senior
$140k - $155k
CRISPR Therapeutics is seeking a Senior Manager, Drug Safety in Boston. This role involves compliance oversight, managing ICSR processing, and developing drug safety SOPs. The successful candidate will have a bachelor's degree and significant experience in pharmacovigilance...Senior- ...are seeking an experienced and commercially minded Senior Director or Executive Director of US Regulatory Strategy to join our growing regulatory consulting... ...late-stage development, registration, and lifecycle management. Serve as regulatory lead for ADCs, bispecific/trispecific...Senior
$232k - $348k
Regulatory Strategy Senior Director The Senior Director of Regulatory Strategy leads the development... ...to the Director of Global Regulatory Affairs. Key Responsibilities Lead the development... .... Counsel and advise senior management on the status of global Regulatory Affairs...SeniorLocal areaRemote workFlexible hours2 days per week3 days per week- Regulatory Strategy Senior Director page is loaded## Regulatory Strategy Senior Directorlocations: Boston, MAtime type: Full... ...and GRA leadership. Counsels and advises senior management on status of global Regulatory Affairs strategies and tactics, procedures and practices...SeniorSummer workLocal areaRemote workFlexible hours2 days per week3 days per week
- ...Senior Executive Director, Regulatory Affairs About the Company Well-funded clinical-stage biotech company Industry Biotechnology Type... ...activities. This includes global regulatory strategy, managing health authority interactions, and ensuring that the...Senior
- ...culture because it is an investment in our people, our future, and what we stand for as a firm. KPMG is currently seeking a Manager or Senior Manager to join our Tax practice. Responsibilities: Provide tax compliance and advisory services to corporations and...SeniorFull timeLocal area
KPMG
Boston, MA4 days ago - Alnylam Pharmaceuticals in Cambridge, MA is seeking a Senior Manager for External Reporting to lead the preparation and filing of SEC reports and oversee compensation accounting. This hybrid role requires strong expertise in U.S. GAAP and SEC reporting, as well as 7+ years...SeniorTemporary work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Affairs Manager. Be the first to apply!
Related searches
- regulatory affairs director Boston, MA
- senior regulatory manager Boston, MA
- senior director regulatory affairs Boston, MA
- regulatory affairs manager medical devices Boston, MA
- regulatory operations manager Boston, MA
- compliance director Boston, MA
- operations compliance manager Boston, MA
- regulatory affairs manager pharmaceutical Boston, MA
- regulatory manager Boston, MA
- regulatory & compliance manager Boston, MA