Director, RA CMC

The Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains 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. Serves as strategic liaison with the regulatory agencies (e.g., FDA) regarding CMC matters. Manages assigned projects within assigned resources. May supervise others.

Responsibilities

• Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new drug applications.
• Advises internal personnel on regulatory strategies. Provides strategic regulatory advice to peers in RA, R&D, and Operations. Seeks internal and external expert advice and technical support when necessary.
• Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies.
• Devises regulatory strategies for complicated scenarios (e.g., complex dosage form or multiple operational changes, aggressive timelines).
• Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions. Serves as the point of contact for the regulatory agency meetings and leads CMC discussion for projects with health authorities.
• Manages products and change control in compliance with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests.
• Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members to maximize chances for first pass approval of regulatory submissions.
• Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation, regulation and guidance and provides analysis to the organization. Leads creation of white papers and policies to illustrate current regulatory thinking.
• Designs initiatives to drive business efficiencies across the organization (within or outside of the regulatory groups). Ensures enterprise culture initiatives are implemented across RA CMC.
• Trains, develops and mentors individuals; may include formal supervisory responsibilities.

Qualifications

• Required Education: Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject
• Preferred Education: Relevant advanced degree preferred. Certification a plus
• Required Experience: 15 years pharmaceutical experience with 5-plus years demonstrated leadership.
• Preferred Experience: 15-plus years pharmaceutical experience, including 10-plus years in regulatory affairs and 10-plus years in Formulation Sciences, R&D, or Manufacturing
• Experience developing and implementing successful global regulatory strategies to support drug development. Extensive new drug application (NDA) experience is required
• Interfacing ability with government regulatory agencies
• Success leading in a complex and matrix environment.
• Strong understanding of the business/enterprise
• Strong oral and written communication skills.
• Note: Higher education may compensate for years of experience.

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. If you would like to view a copy of the company's affirmative action plan or policy statement, please email [email protected].