Associate Principal Scientist, Regulatory Liaison

About the role

The Regulatory Affairs Headquarters Associate Principal Scientist supports Vaccine and Infectious Disease products, working closely with a global liaison to develop and implement global registration strategies.

Key responsibilities

• Assist in regulatory agency communications and submissions, including INDs, marketing applications, pediatric plans, and periodic reports.
• Develop agency background packages, author regulatory strategy documents, and track responses to agency requests.
• Participate in global regulatory team meetings and cross‑functional collaborations.
• Conduct research on guidelines, regulatory precedents, and competitive intelligence to shape strategy.
• Support label development, lifecycle management, and process improvement initiatives.

Required profile

• Ph.D., M.D., or related doctoral degree in biological science, chemistry, or a related discipline (or equivalent experience with a master’s or bachelor’s degree).
• Minimum 3 years of relevant pharmaceutical industry experience with a bachelor’s degree, or 6 years with a bachelor’s, or 3 years with a master’s.
• Excellent oral and written communication, strong organizational abilities, and attention to detail.

Required skills

• Regulatory submissions (INDs, marketing applications, pediatric plans, annual reports).
• Regulatory strategy development and agency communication.
• Research of regulatory guidance, precedents, and competitive intelligence.

What we offer

• Salary range $142,400 – $224,100 per year, with eligibility for annual bonus and long‑term incentives.
• Comprehensive benefits including medical, dental, vision, 401(k), paid holidays, vacation, and sick days.