Analytical Regulatory Author & Strategist (R4 - R5 Level) (Secondment - 12 Months)

Pfizer•St Louis, MO

5d•Hybrid

About The Position

This secondment position is considering applicants at the R4 to R5 levels. At Pfizer, our purpose is to deliver breakthroughs that change patients' lives. Central to this mission is our Research and Development team, which strives to translate advanced science and innovative technologies into impactful therapies and vaccines. Whether you are involved in discovery sciences, ensuring drug safety and efficacy, or supporting clinical trials, your role is crucial. You will leverage cutting-edge design and process development capabilities to accelerate the delivery of best-in-class medicines to patients globally.

Requirements

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.

Nice To Haves

Master's degree with at least 7+ years of experience; OR a PhD with 0 + years of experience.
Demonstrated ability to work independently to identify strategic opportunities for process improvement, proactively expand functional capabilities, and lead initiatives that broaden group scope, responsibilities, and organizational impact in support of evolving business needs.
Experience leveraging AI and generative AI tools to enhance productivity and problem-solving, while proactively identifying and implementing new AI solutions to expand team capabilities and efficiency.
Prior experience as an ARD Lead, BIS Rep, CAS Rep, and/or CAS-HC Rep.
Strong attention to detail and accuracy.
Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance.

Responsibilities

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.