Director, Regulatory Affairs
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 Director, Regulatory Affairs, is independently responsible for development of global regulatory strategy and representation of Regulatory Affairs on R&D project teams. Communicates regulatory strategy to project teams developing pharmaceutical/biologic/combination products. Leads team of regulatory professionals to ensure successful planning and completion of regulatory activities on a worldwide basis. Responsible for knowledge of regulatory requirements of major regions (US, EU, Japan and China) with responsibility for working with colleagues on a worldwide basis to form a global strategy. Responsible for content of global regulatory submissions, including US submissions. Directs communications and interactions with US FDA and other regulatory agencies worldwide. Responsible for covering multiple development projects in US and international.
Represents Department at Global Project Team. Develops regulatory strategic plan and provides guidance to project team. Leads Global Regulatory Team. Works with team to resolve complex project issues. Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained. Manage and/or mentor direct report(s), where line management responsibilities exist.
Sets strategy for submissions of product registration documents to health authorities worldwide. Interacts with other line functions in the preparation, review, and completion of documents for regulatory submissions. Oversees US submissions, and as needed, independently prepares submissions, including PMA, IDE, and associated supplements/reports.
Able to clearly articulate regulatory strategy at Project Team and Global Regulatory Team meetings. Able to negotiate with teams to ensure acceptance of regulatory strategy. Ensures compliance with project team timelines and milestones.
Health Authority Interactions: Effectively plan, organize, and conduct (or supervise) formal meetings with regulatory agencies. Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications.
Regulatory Compliance: Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that affect AbbVie’s products and operations. Advise personnel in other departments regarding their applicability and effect.
- PhD, PharmD or MD degree or equivalent in a scientific field, plus at least 8 years’ experience in Regulatory Affairs with successful leadership roles on global project teams
- MS degree or equivalent in a scientific field, plus at least 10 years’ experience in Regulatory Affairs with successful leadership roles on global project teams
- BS degree or equivalent in a scientific field, plus at least 12 years’ experience in Regulatory Affairs with successful leadership roles on global project teams
- Strategic thinking, leadership skills, assertiveness, strong technical background, and excellent negotiation and project management skills as evidenced by past performance as regulatory lead on global project teams.
- Able to analyze worldwide regulatory requirements to synthesize a global regulatory development strategy as evidenced by past regulatory experience
- Excellent interpersonal skills
- Exceptional communication skills (verbal and written) as evidenced by a demonstrated ability to prepare complex documents / submissions and to give presentations
- Experience working in a matrixed environment
- Ability to work independently
- Ability to travel upto 30%
- Demonstrated excellence in developing global regulatory affairs strategy for Class III medical devices. Experience with combination products or in pharma is a plus.
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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.