Associate Principal Scientist (Associate Director) - Regulatory Liaison
Merck, North Wales, PA, United States
Associate Principal Scientist – Vaccine & Infectious Disease
Department: Global Regulatory Affairs and Clinical Safety – Vaccine & Infectious Disease
Job Description: The Regulatory Affairs Headquarters Associate Principal Scientist supports products in the Vaccine and Infectious Disease (VID) therapeutic area as part of a regulatory team. They will have excellent communication and collaboration skills and will work closely with a global liaison(s) to help develop and implement a global strategy for registration and/or maintenance of VID products. Responsibilities may encompass all aspects of planning and implementation of a global regulatory strategy and regulatory submissions, including assistance in preparing submissions, protocol review, and research on regulatory guidances or competitive intelligence.
Primary Activities
Assists in regulatory agency communications and submissions, including marketing applications, Investigational New Drug Applications (INDs), pediatric plans, and annual or other periodic reports. May take lead on tracking, authoring, shepherding, and reviewing agency responses.
Implements strategy to develop agency background packages and documents for marketing application submissions.
Communicates with agencies and attends agency meetings to assist the Global Liaison.
Participates as an active member of the Global Regulatory Team, attending cross‑functional meetings to assist the global liaison.
Conducts research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy. Assists the global liaison in authoring regulatory strategy documents.
Collaborates and communicates regulatory strategy to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and Control (CMC) and other functional areas.
Supports maintenance (quality compliance and life‑cycle management) of VID programs.
Supports Global Liaison in label development.
Assists with process improvement initiatives.
Performs regulatory administrative activities as needed.
Qualifications
Education: M.D., Ph.D., or other related doctoral degree in biological science, chemistry or related discipline; Master’s or Bachelor’s degree with sufficient experience can substitute.
Experience: Master’s degree with at least 3 years of relevant experience in the pharmaceutical industry, or Bachelor’s degree with at least 6 years of relevant experience.
Excellent communication (oral and written), strong organizational skills, and ability to handle multiple projects simultaneously.
Flexibility, strong scientific and analytical skills with attention to detail.
Preferred Experience
Prior regulatory experience.
Experience in drug development, particularly anti‑infectives and/or vaccine products.
Job Details
Reports to: Associate Vice President, Section Head or Distinguished Scientist.
Job Level/Grade: 400.
Location: USA‑Pennsylvania‑North Wales‑Upper Gwynedd (Hybrid – 3 days per week in office). Additional locations: USA‑New Jersey‑Rahway; USA‑Pennsylvania‑Philadelphia‑WeWork.
Travel: 10%.
Relocation: No.
VISA Sponsorship: No.
Equal Employment Opportunity This company is an Equal Employment Opportunity Employer and complies with all applicable federal and state laws.
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Job Description: The Regulatory Affairs Headquarters Associate Principal Scientist supports products in the Vaccine and Infectious Disease (VID) therapeutic area as part of a regulatory team. They will have excellent communication and collaboration skills and will work closely with a global liaison(s) to help develop and implement a global strategy for registration and/or maintenance of VID products. Responsibilities may encompass all aspects of planning and implementation of a global regulatory strategy and regulatory submissions, including assistance in preparing submissions, protocol review, and research on regulatory guidances or competitive intelligence.
Primary Activities
Assists in regulatory agency communications and submissions, including marketing applications, Investigational New Drug Applications (INDs), pediatric plans, and annual or other periodic reports. May take lead on tracking, authoring, shepherding, and reviewing agency responses.
Implements strategy to develop agency background packages and documents for marketing application submissions.
Communicates with agencies and attends agency meetings to assist the Global Liaison.
Participates as an active member of the Global Regulatory Team, attending cross‑functional meetings to assist the global liaison.
Conducts research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy. Assists the global liaison in authoring regulatory strategy documents.
Collaborates and communicates regulatory strategy to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and Control (CMC) and other functional areas.
Supports maintenance (quality compliance and life‑cycle management) of VID programs.
Supports Global Liaison in label development.
Assists with process improvement initiatives.
Performs regulatory administrative activities as needed.
Qualifications
Education: M.D., Ph.D., or other related doctoral degree in biological science, chemistry or related discipline; Master’s or Bachelor’s degree with sufficient experience can substitute.
Experience: Master’s degree with at least 3 years of relevant experience in the pharmaceutical industry, or Bachelor’s degree with at least 6 years of relevant experience.
Excellent communication (oral and written), strong organizational skills, and ability to handle multiple projects simultaneously.
Flexibility, strong scientific and analytical skills with attention to detail.
Preferred Experience
Prior regulatory experience.
Experience in drug development, particularly anti‑infectives and/or vaccine products.
Job Details
Reports to: Associate Vice President, Section Head or Distinguished Scientist.
Job Level/Grade: 400.
Location: USA‑Pennsylvania‑North Wales‑Upper Gwynedd (Hybrid – 3 days per week in office). Additional locations: USA‑New Jersey‑Rahway; USA‑Pennsylvania‑Philadelphia‑WeWork.
Travel: 10%.
Relocation: No.
VISA Sponsorship: No.
Equal Employment Opportunity This company is an Equal Employment Opportunity Employer and complies with all applicable federal and state laws.
#J-18808-Ljbffr