Senior Manager, Regulatory Affairs

Overview

Represent Regulatory Affairs in cross-functional internal project teams and improvement initiatives, providing regulatory positions on CMC topics. Manage collection, review, coordination, and preparation of documentation for regulatory CMC submissions, maintain trackers for documentation requests and timelines, and coordinate responses to regulatory queries. Ensure conformance to commitments with regulatory agencies. Collaborate with cross-functional teams and external partners to develop regulatory strategies and identify regulatory risks.

Responsibilities

• Represent Regulatory Affairs in cross-functional project teams and improvement initiatives, providing regulatory positions on CMC topics.
• Manage the collection, review, coordination, and preparation of documentation for regulatory CMC submissions, including maintaining comprehensive trackers for documentation requests and timelines.
• Prepare responses to queries from regulatory authorities.
• Ensure conformance to commitments made with regulatory agencies.
• Collaborate with cross-functional project teams and external business partners to develop regulatory strategies and identify regulatory risks.
• Coordinate the timely submission of regulatory documents and filings.
• Review and approve change controls related to proposed product/process changes and assess their impact against regulatory requirements.
• Cultivate productive working relationships with the Regulatory team and other departments.
• Coordinate responses to CMC-related queries from health authorities.

Qualifications

• Bachelor of Science in a scientific discipline (Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices).
• 9+ years of experience in vaccine or biotech industry, or in a related field, or the equivalent combination of education and experience.
• Prior experience preparing/authoring CMC DS sections.
• BLA highly preferred.
• IND highly preferred.
• IMPD experience.
• Prior development or manufacturing experience is a plus.
• Experience with module 32S and 32P.
• Computer software skills (LIMS, SAP, TrackWise, Veeva).
• Ability to meet multiple deadlines across a variety of projects/programs with a high degree of accuracy and efficiency.
• Applies in-depth understanding of how own discipline integrates within the function and contributes to business objectives.