Manager, RA CMC
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
This position will execute CMC projects within the Global Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) organization by actively contributing to the development and implementation of global CMC regulatory strategies throughout the lifecycle of biologics and device/biologics combination products.
- Execute and manage the implementation of Regulatory CMC strategy.
- Management of regulatory assessments and notifications with change control system.
- Functions as primary contact for CMC issues with regulatory authorities for assigned products and projects. Prepares and issues Regulatory Agency Telephone Contact Reports and Meeting Minutes.
- Actively participate in project team meetings and provide leadership in meeting submission goals.
- Determines nature, scope and format of CMC information to be generated in order to successfully: file and maintain INDs/CTAs; file regulatory dossiers; respond to health authority inquiries; and obtain and maintain market approval for development and approved products.
- Manages response team for regulatory agency CMC inquiries.
- Administers preparation of briefing and presentation materials for Regulatory Agency meetings.
- Represents Regulatory Affairs CMC on project teams for assigned products/projects.
- Regulatory environment, regulatory submission and/or pharmaceutical healthcare environment.
- Business and personal computer hardware and software applications.
- Excellent written and verbal communication, presentation, and facilitation skills
- Collaborate with management to develop appropriate regulatory strategy.
- Interpret global regulations and apply Health Authority guidance to the development of CMC regulatory documentation.
- Establish strong working relationships within the project teams by proactively managing global CMC strategies, submissions, and timelines.
- Work independently to prioritize and manage multiple projects and assignments.
- Ability to build bridges between diverse groups of stakeholders.
- Pharmaceutical manufacturing facility/development laboratory preferred.
- Experience in the preparation and management of regulatory submissions including experience in preparation of responses to issues raised by global Health Authorities.
- Global registration support.
- Perform regulatory assessments in a cGMP change control environment.
- Sound basis of Scientific (Training/Communications) knowledge in multiple areas
- Demonstrated ability to prepare and manage ensure thoroughness, and accuracy of global CMC dossiers.
- Ability to handle multiple assignments and prioritize work independently.
- Experience with biologics products
- B.S. required in related scientific discipline with a minimum of 2+ years of regulatory CMC experience and 4+ years of pharmaceutical, biologics or related, experience.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity 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.