Associate Principal Scientist, Regulatory Liaison

Brief Description of 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 guidance's or competitive intelligence.

Primary activities include, but are not limited to:

• 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.

Qualifications, Skills, and Experience

Education Minimum Requirements:

• M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline. Other degrees such as master's or bachelor’s with experience to suggest equivalent ability to function in this position.

Required Experience and Skills:

• 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 different activities or multiple projects.
• Flexibility required.
• Strong scientific and analytical skills with attention to detail.

Preferred Experience and Skills:

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

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The salary range for this role is

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

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.