AbbVie Associate Director, Regulatory Affairs CMC in North Chicago, Illinois
AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie at https://twitter.com/abbvie on Twitter, Facebook at https://www.facebook.com/AbbVieCareers/ or LinkedIn at https://www.linkedin.com/company/abbvie/jobs .
The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners in order to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and managers content strategy for regulatory submissions, including new marketing applications, supplements and variations. Builds and maintains relationships within the regulatory affairs functional areas, Operations and Research and Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams and Operations brand teams to negotiate, influence, and provide strategic advice. Serves as liaison and strategic partner with the regulatory agencies (e.g. FDA). Manages assigned projects within assigned resources. May supervise others
Key Responsibilities Include :
Identifies and collects data needed and prepares CMCregulatory product strategies. Seeks expert advice and technical supportas required for strategies and submissions.
Manages the preparation of CMC submissions.Prepares and manages regulatory applications, including new applicationsand amendments, renewals, annual reports, supplements and variations underlimited supervision. Reviews and revises regulatory submissions toeffectively present data and strategy to regulatory agencies.
Manages products and change control in compliance withregulations and company policies and procedures. Analyzes and approvesmanufacturing change requests.
Develops strategies for CMC meetings, managepreparation for agency meetings and manages content of pre-meetingsubmissions. Serves as the point of contact for the regulatoryagency meetings.
Regularly informs regulatory management of importanttimely issues.
Trains, develops and mentors individuals; may includeformal supervisory responsibilities.
Develops and implements policies and procedureswithin the regulatory affairs department.
Analyzes legislation, regulation and guidance andprovides analysis to the organization.
Represents CMC regulatory affairs on teams such as theproduct development, Global Regulatory Product Teams and Operations brandteams, for assigned projects; negotiates with and influences team membersto maximize chances for first pass approval or regulatory submissions.
Represents CMC regulatory affairs on projectinitiatives with other groups to drive efficiencies across the company.
Supports combination products and medical devicesincluding design control and change management activities
Required Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
Preferred Education: Relevant advanced degree preferred.
Required Experience: 8 years pharmaceutical or industry related experience. Proven 3+ years in a leadership role with strong management skills
Experience working in a complex and matrix environment.
Strong communication skills, both oral and written.
Preferred Experience: 5 years’ experience in Regulatory Affairs. 10 years pharmaceutical experience (drug/medical device/combination product). 5 years in Discovery, R&D or Manufacturing
Experience developing and implementing successful global regulatory strategies. Experience working with Health Authority
Note: Higher education may compensate for years of experience
Title can be flexible depending on experience
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Keyboard use (greater or equal to 50% of the workday)
Yes, 5 % of the Time
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.