Associate Director, 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:
- Independently provide tactical and strategic leadership on complex 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, pharmaceuticals, and device/drug combination products.
- Participate in Due Diligence activities
- Interpret, apply and implement global regulations to CMC projects and prepare CMC regulatory submissions.
- Actively participate in project team meetings and provide leadership in meeting submission goals
- Identify and manage resolution to routine and complex issues including regulatory risk and provide risk/benefit strategies
- Represent RA CMC in preparation meetings with Health Authorities
Education and Experience
- B.S. required in related scientific discipline with a minimum of 11 years of regulatory experience, including managing people or projects. Or, MS degree and 9 years of regulatory experience, or PhD and 6 years of regulatory experience.
- Experience in a pharmaceutical manufacturing facility/development laboratory preferred.
- Sound basis of Scientific (Training/Communications) knowledge in multiple areas
- Expert knowledge of regulations, and experience with interpretation and application
- Excellent written and verbal communication, presentation, and facilitation skills
- Strong negotiation skills and significant experience in interacting with regulatory authorities
- Risk identification and problem solving skills
- Demonstrated ability to lead, mentor, and develop others for future growth and development;
- Established relationships with regulatory authorities
- Ability to travel
- Proficiency with common office software applications
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.