Prepares CMC regulatory product strategies. Seeks expert advice and technical support as required for strategies and submissions
Manages the preparation of CMC submissions. Prepares and manages regulatory applications, including new applications and amendments, renewals annual reports, supplements and variations
Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies
Manages products and change control in compliance with regulations and company policies and procedures. Analyzes and approves manufacturing change requests.
Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of briefing documents
Regularly informs regulatory management of important timely issues
Trains, develops and mentors individuals; may include formal supervisory responsibilities
Develops and implements policies and procedures within the regulatory affairs department
Analyzes legislation, regulation and guidance, provides analysis to the organization
Support combination products and medical devices including design control and change management activities. Provides regulatory guidance and support for risk management and human factors engineering topics for drug, biologic, device and combination products
Required Education: Bachelor’s Degree in Pharmacy, Chemistry, Biology or Pharmacology or related subject
At AbbVie, we have the expertise of a proven pharmaceutical leader and the focus and passion of an entrepreneur and innovator. The result is something rare in health care today – a global biopharmaceutical company that has the ability to discover and advance innovative therapies and meet the health needs of people and societies around the globe.