Analytical Regulatory Author & Strategist, R4 - R5 Level

Pfizer

Analytical Regulatory Author managing BLA submissions and collaborating on regulatory strategies. Assisting with analytical data integration and enhancing authoring processes using AI technologies.

Posted 7/11/2026full-timeSt. Louis • Massachusetts, Montana, Washington • 🇺🇸 United StatesSeniorLeadWebsite

About the role

Key responsibilities & impact

Support the group's core analytical authoring objectives for upcoming ongoing BLA submissions
Assist in the authoring of analytical sections, ensuring alignment with regulatory strategy, platform precedents, and health authority expectations
Help drive integration and interpretation of analytical data (release, stability, characterization) into clear, defensible regulatory narratives
Identify, evaluate, and implement emerging AI and digital technologies to enhance regulatory authoring processes, improve team efficiency, and expand the group's capabilities in support of evolving business needs
Assist in developing and refining ARD regulatory strategy to ensure consistent, defensible submission narratives
Leverage your individual background and expertise to expand the groups scope into additional analytical areas (e.g., stability, method development/evolution, comparability)
Assist in the development of analytical strategies and template guidance for CTD sections in collaboration with ARD SME’s

Requirements

What you’ll need

Applicant must have a bachelor's degree with at least 9+ years of experience
Experience in biological drug development and familiarity with analytical strategies to support product development and evaluate the quality and characteristics of biotherapeutics
Experience working in interdisciplinary drug development teams
Direct experience with clinical and commercial biologics submissions
Experience in developing and implementing analytical control strategies for biotherapeutics
Strong communication skills and the ability to work independently
Experience with both analytical laboratory data and process-relevant data
Strong written and verbal communication skills
Proficiency in MS Office
Ability to manage multiple projects and prioritize tasks effectively
Master's degree with at least 7+ years of experience; OR a PhD with 0 + years of experience preferred
Demonstrated ability to work independently to identify strategic opportunities for process improvement
Experience leveraging AI and generative AI tools to enhance productivity and problem-solving

Benefits

Comp & perks

May require occasional travel to other sites

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Analytical AuthoringRegulatory Strategy DevelopmentData Integration and InterpretationAnalytical Method DevelopmentProject Management

Soft Skills

Strong Communication SkillsIndependent WorkTeam CollaborationProblem-Solving