Senior Principal Scientist, Regulatory Liaison
$190.8k - $300.3kMerck
Senior Principal Scientist in Regulatory Affairs at Merck responsible for developing and implementing worldwide regulatory strategies for General Medicine and Immunology programs. The role involves independent project management, direct agency interactions, and leadership of regulatory teams to optimize labeling and accelerate product approvals.
Responsibilities
- Develop worldwide regulatory strategies to optimize product labeling and accelerate time to approval
- Serve as global regulatory lead and single point-of-contact for assigned investigational and marketed products
- Lead cross-functional regulatory teams coordinating support for development programs and marketed products
- Independently coordinate with regulatory agencies including FDA and EMA on submissions and strategy discussions
- Prepare IND/CTAs, clinical study reports, protocols, and worldwide marketing applications for regulatory review
Requirements
- B.S. or M.S. with 10+ years drug development experience, majority in regulatory affairs
- M.D., PhD, or PharmD with 7+ years drug development and 5+ years regulatory experience
- Strong strategic thinking, problem-solving, and continuous learning capability
- Direct interaction experience with FDA, EMA, and other major health authorities
- Demonstrated expertise leading regulatory strategies across global regions and markets
- Leadership experience building and managing high-performing teams or complex projects
- Immunology therapeutic area expertise strongly preferred
Compensation: $190,800–$300,300 base
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Principal Scientist, Regulatory Liaison in Upper Gwynedd, PA vacancy
$190.8k - $300.3k
...Senior Principal Scientist in Regulatory Affairs at Merck responsible for developing and implementing worldwide regulatory strategies for General Medicine and Immunology programs. The role involves independent project management, direct agency interactions, and leadership...PrincipalSeniorRegulatoryWorldwide$173.2k - $272.6k
...Principal Scientist position in regulatory affairs for immunology programs at Merck, responsible for developing global regulatory strategies and serving as the primary regulatory contact for assigned investigational and marketed drugs. The role requires independent project...PrincipalRegulatoryWorldwide$142.4k - $224.1k
...Associate Principal Scientist supporting vaccine and infectious disease products within a regulatory affairs team. The role involves developing global regulatory strategies, preparing submissions, and collaborating across functional teams to ensure product registration...PrincipalRegulatory$282.2k
...Senior Principal Scientist position leading clinical research strategy and execution for oncology drugs across all development phases. Responsible for study design, trial management, regulatory submissions, and cross-functional collaboration within a global healthcare...PrincipalSeniorRegulatory$190.8k - $300.3k
...Senior Principal Scientist leading nonclinical drug safety strategy for immunology programs at Merck. Responsible for overseeing development progression, regulatory submissions, and post-marketing support while mentoring scientists and influencing cross-functional partnerships...PrincipalSeniorRegulatory- Merck seeks a Principal Scientist to lead the Analytical Commercialization Technology group at Rahway, NJ and West Point, PA, driving late... ..., oversee method development and validation, contribute to regulatory submissions, and collaborate across regulatory, research, and...PrincipalRegulatory
$156.9k - $247k
...person will lead several Human Factors scientists to perform and manage human factors activities... ...ensure compliance with US and global regulatory policies/guidance for all combination... ...Responsibilities and Activities:The Principal Scientist is responsible for managing a...PrincipalRegulatoryFull timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
West Point, PA3 days ago$173.2k - $272.6k
...treatment of diseases in people and animals.We are seeking a Principal Scientist to join our Analytical Commercialization Technology (ACT)... ...Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions, and responses to regulatory questions.The...PrincipalRegulatoryFull timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
West Point, PA3 days ago$260.3k - $409.7k
...DescriptionWe have an exciting opportunity for a physician-scientist to join our group as a Principal Scientist (Clinical Director) in Translational... ...stages of development, from Phase 3 through to worldwide regulatory applications.Success depends on the integrity, knowledge...PrincipalRegulatoryFull timeFor contractorsLocal areaWorldwideFlexible hoursMerck Sharp & Dohme (MSD)
West Point, PA4 days ago$173.2k - $272.6k
Job DescriptionJob Description Summary: Principal Scientist/Director, Biologics Drug Substance... ...Substance Commercialization (BDSC). This senior leadership role is responsible for... ...in process characterization, ensuring regulatory compliance, collaborating across cross...PrincipalRegulatoryFull timeContract workFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
West Point, PA4 days ago$117k - $184.2k
Job DescriptionSenior Scientist - Exploratory Vaccines and Regulated RoboticsWe are seeking a highly motivated Senior Scientist to join the Exploratory Vaccines and Regulated Robotics... ...with applicable SOPs, test methods, and regulatory expectations.QualificationsRequiredPh.D....SeniorRegulatoryFull timeFor contractorsLocal areaMerck Sharp & Dohme (MSD)
West Point, PA2 days ago$117k - $184.2k
...prevention and treatment of diseases in people and animals.As a Senior Scientist in Process Analytics, you’ll be at the forefront of... ...for implementation.Author technical protocols, reports, and regulatory documents in support of process comparability studies.Demonstrate...SeniorRegulatoryFull timeFor contractorsLocal areaMerck Sharp & Dohme (MSD)
West Point, PA14 hours ago$168k - $199k
...reports, internal and external scientific meeting presentations and peer-reviewed publications, and all regulatory submission documents \n Manages the process and liaisons required to support external study oversight committees (e.g. steering committees, independent data...PrincipalRegulatoryRelocation packageCSL
King of Prussia, PA5 days ago$190.8k - $300.3k
...company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state... ...methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and...PrincipalRegulatoryContract workWork experience placementLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work$96.68k - $120.85k
...LSRPs) and other technical specialists.As a senior member of the team, you will apply your... ...technical deliverables, and support regulatory and client communications. You will also... ...to early-career and mid-level Geological Scientists and contribute to the development of team...SeniorRegulatoryFull timeWork at officeRamboll Group
Blue Bell, PA2 days ago$190.8k - $300.3k
...company’s renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state... ...methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and...PrincipalRegulatoryFor contractorsWork experience placementLocal areaRelocationVisa sponsorshipFlexible hoursShift work$117k - $184.2k
Job Description Join Our Team as a Biologics Conjugation Senior Scientist! We are seeking a strategic and technical scientist with expertise... ...support process characterization, right first time PPQ and regulatory filings. You will engage our program team members to...SeniorRegulatoryContract workFor contractorsRelocationVisa sponsorshipFlexible hoursShift work$231.9k - $365k
...A senior anatomic pathologist position at a research-intensive biopharmaceutical company's nonclinical safety department in Pennsylvania. The role involves leading toxicological pathology evaluations, interpreting drug safety data, and collaborating across cross-functional...PrincipalSenior$255.8k - $402.7k
...Principal Scientist role overseeing clinical research activities for oncology medicines across all development phases. Responsibilities include study design, trial management, regulatory reporting, and cross-functional collaboration to advance new and marketed drugs through...PrincipalRegulatory$190.8k - $300.3k
...Principal Scientist role in Biostatistics leading late-stage clinical development projects. Provides statistical expertise for drug and vaccine... ...cross-functional teams, and ensures compliance with regulatory requirements throughout the clinical trial lifecycle. Responsibilities...PrincipalRegulatoryWorldwide$173.2k - $272.6k
...Merck seeks a Principal Scientist in Drug Metabolism and Pharmacokinetics to support multi-disciplinary drug development and discovery efforts... ...and biologics, assessing program risks, authoring regulatory documents, and guiding clinical development teams in a collaborative...PrincipalRegulatory- ...real, and careers are built intentionally. We’re looking for a Senior Indirect Tax Accountant who’s sharp, collaborative, and ready to... ..., and controls around indirect tax Stay current on regulatory changes and assess business impact What We’re Looking For 2+ years...SeniorRegulatoryFlexible hours
Xplora Search Group
Oaks, PA2 days ago $156.9k - $247k
...Principal Scientist position leading a Human Factors team at a pharmaceutical company to develop combination products and medical devices... ...factors activities across the product lifecycle while ensuring regulatory compliance and mentoring junior scientists....PrincipalRegulatory$260.3k - $409.7k
...Merck seeks a physician-scientist to lead translational medicine and early clinical development for infectious disease therapeutics.... ...experimental medicine and cross-functional collaboration Provide regulatory and scientific support for clinical trial design and filing...PrincipalRegulatory$109k - $174.8k
...patients every step of the way. Learn more at Position Summary Senior Scientist - Data (AI) Scientist, Translational Safety to join the Data... ...produce explainability and validation packages suitable for regulatory and cross‑functional review. Prototype and advance...SeniorRegulatoryWork at officeLocal areaImmediate start$255.8k - $402.7k
...Merck seeks a physician-scientist to lead translational medicine and early clinical development for neuroscience therapeutics. The role... ...validation, clinical trial design, biomarker development, and regulatory support for neurologic and psychiatric disease programs....PrincipalRegulatory$173.2k - $272.6k
...Merck seeks a Principal Scientist to lead analytical chemistry efforts for small molecule drug product development and commercialization.... ..., conducting method development and validation, supporting regulatory submissions, and mentoring scientists in a cGMP manufacturing...PrincipalRegulatory$255.8k - $402.7k
...Principal Scientist leading clinical research strategy and execution for investigational immunology compounds at a late-stage development level. Responsible for clinical trial design, regulatory submissions, cross-functional collaboration, and maintaining scientific expertise...PrincipalRegulatory- GSK in Collegeville, PA seeks a Scientist/Sr. Scientist for bioassay development, validation and tech transfer. You will develop and validate... ...automation teams to ensure high-quality data, scalability and regulatory compliance, contributing to drug development. #J-18808-Ljbffr...SeniorRegulatory
- GSK US in Pennsylvania is seeking a Scientist or Senior Scientist in Formulation and Process Development to advance biopharmaceutical drug... ...writing, data integrity, collaboration with Analytical Development and Manufacturing Sciences, and regulatory #J-18808-Ljbffr GSKSeniorRegulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Principal Scientist, Regulatory Liaison. Be the first to apply!
