The Sr. Director Regulatory Affairs (Devices) 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 or medical device 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. Directs communications and interactions with US FDA and other regulatory agencies worldwide. Responsible for covering multiple development projects.
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 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.
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.
Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that affect Allergan Aesthetics products and operations. Advise personnel in other departments regarding their applicability and effect.-PD1
Qualifications - External
- PhD, PharmD or MD degree or equivalent in a scientific field, plus at least 10 years’ experience in Regulatory Affairs with successful leadership roles on global project teams
- MS degree or equivalent in a scientific field, plus at least 12 years’ experience in Regulatory Affairs with successful leadership roles on global project teams
- BS degree or equivalent in a scientific field, plus at least 15 years’ experience in Regulatory Affairs with successful leadership roles on global project teams
- Demonstrated excellence in developing global regulatory affairs strategy.
- 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 for up to 20% (to include International Travel)
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action 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. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.