Senior Associate/Manager, RA CMC

About AbbVie
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.

 

The Manager, Regulatory Affairs, Chemistry Manufacturing & Controls (CMC) develops & manages regulatory submission content strategies for drugs, devices, and/or combination products, including clinical trial applications, new market applications, and post-approval variations. Prepares CMC regulatory strategies that enable first pass approvals under management supervision; builds & maintains relationships within the regulatory affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents CMC regulatory affairs on teams such as the product development & Operations brand teams to negotiate, influence & provide strategic advice.
 

Key Responsibilities Include:

• Prepares CMC regulatory product strategies with limited supervision. Seeks expert advice and technical support as required for strategies and submissions.
• Prepares regulatory applications under limited supervision, including new investigational applications and amendments, new marketing applications and post-approval supplements, renewals, and annual reports.
• Manages products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change plans, as required.
• Develops strategies for CMC meetings with regulatory agencies and manages the content and preparation of information packages for pre-meeting submissions
• Regularly informs regulatory management of important issues in a timely manner
• Analyzes legislation, regulation and guidance and provides analysis to the organization
• Represents CMC regulatory affairs on product development teams, 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

Qualifications

Qualifications

• Required Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject
• Preferred Education: Relevant advanced degree preferred
• Required Experience: 6+ years biopharmaceutical industry related experience. 3-5 years in quality systems or cross-functional project management
• Preferred Experience: 5+ years’ experience in R&D or Manufacturing. 5+ years’ experience in Regulatory Affairs (biopharmaceutical/combination product)
• Experience working in a complex and matrix environment
• Strong communication skills, both oral and written
•  Note: Higher education may compensate for years of experience

Significant Work Activities
Keyboard use (greater or equal to 50% of the workday)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
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.