Associate Principal Scientist (Associate Director) - Regulatory Liaison

Merck • North Wales, PA

5d • Hybrid

About The Position

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 assisting in preparing submissions, protocol review, and conducting research on regulatory guidances or competitive intelligence.

Requirements

• M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline, or Master’s degree with at least 3 years of relevant experience in pharmaceutical industry, or
• Bachelor’s degree with at least 6 years of relevant experience in the pharmaceutical industry
• Excellent communication skills (both oral and written).
• Good organizational skills with a proven ability to simultaneously balance activities or multiple projects.
• Flexibility required.
• Strong scientific and analytical skills with attention to detail.

Nice To Haves

• Prior regulatory experience.
• Experience in drug development, particularly anti-infectives and/or vaccine products is highly preferred.

Responsibilities

• Assists in regulatory agency communications and submissions, including but not limited to: marketing applications, Investigational New Drug Applications (INDs), 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.
• Implements strategy to develop agency background packages and documents associated with regulatory submissions for marketing applications.
• Communicates with agencies and attending agency meetings to assist the Global Liaison.
• Participates as an active member on the Global Regulatory Team. They will attend cross-functional meetings as required, in collaboration with, and 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 of regulatory strategy documents.
• Collaborates and communicates 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, Safety Assessment).
• Supports maintenance (e.g., quality compliance and life cycle management) of VID programs.
• Supports of Global Liaison in label development.
• Assists with process improvement initiatives.
• Performs regulatory administrative activities as needed.

Benefits

• 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 https://jobs.merck.com/us/en/compensation-and-benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree