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. Directs communications and interactions with US FDA and other regulatory agencies worldwide. May have responsibility to work in one or more therapeutic areas, covering multiple development projects.
Main Areas of Responsibilities
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 impact Allergan’s products and operations. Advise personnel in other departments regarding their applicability and impact.
Demonstrated excellence in developing global regulatory affairs strategy for pharmaceuticals/biologics/combination products
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
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
Internal Number: 184488
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.