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The Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) - Biologics Product Lead, works with internal and external partners in order to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals under limited management supervision. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations with limited management supervision. Builds and maintain relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents RA CMC on product development and life-cycle management teams to negotiate, influence, and provide strategic advice to peers in RA, R&D, and Operations.
Responsibilities
Prepares CMC regulatory product strategies with limited supervision.
Prepares regulatory submissions, including new IND/CTA applications and amendments, renewals, annual reports, supplements and variations under limited supervision.
Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions.
Reviews and revises regulatory submission documentation to effectively present data and strategy to regulatory agencies under limited supervision.
Responds to global regulatory information requests under limited supervision.
Develop strategies for CMC-related agency interactions and manage preparation of agency meeting requests and information packages, under limited supervision.
Manage products and change control with an understanding of regulations, agency guidance and company policies and procedures with limited supervision. Analyzes and approves manufacturing change records with limited supervision.
Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations Product Teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions and stays abreast of regulatory procedures and changes in the external regulatory environment.
Analyzes legislation, regulation and guidance and provides analysis to the organization under limited supervision.
Contributes to creation of white papers and policies to illustrate current regulatory thinking under supervision of manager. Participates in initiatives internal to RA CMC.
May act as a formal or informal mentor to others.
Requirements
Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
6 years’ biopharmaceutical or related industry experience.
Experience working in a complex and matrix environment.
Strong oral and written communication skills.
Nice-to-haves
Relevant advanced degree preferred.
Certification a plus.
6 years biopharmaceutical RA, R&D or Operations experience including 3 years in regulatory affairs.
