The Director Regulatory Strategy will be independently responsible for development of global regulatory strategy and representation of Regulatory Affairs on R&D project teams. Communicates regulatory strategy to global project teams developing pharmaceutical products. Leads team of regulatory professionals to assure successful planning and completion of regulatory activities on a worldwide basis. Responsible for knowledge of regulatory requirements of major regions 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.
- Submissions: 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.
- Communications: Able to clearly articulate regulatory strategy at Global Project and Global Regulatory Team meetings. Able to negotiate with team to assure acceptance of regulatory strategy. Assures 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 impact Allergan’s products and operations. Advise personnel in other departments regarding their applicability and impact.
The following listed requirements need to be met at a minimum level to be considered for the job:
At least ten (10) years of professional work experience within the R&D, preferably to include at minimum 7 years experience in Regulatory Affairs. (Strategy, Clinical)
- 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 on drug development project teams
- Able to analyze worldwide regulatory requirements to synthesize a global regulatory development strategy as evidenced by past regulatory experience
- Experience working in a matrixed environment
Bachelor’s degree required; Advanced life science degree preferred.