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 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.
- Advisory 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 affect Allergan’s products and operations. Advise personnel in other departments regarding their applicability and effect.
- Required Education: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject). Preferred Education: Relevant advanced degree is preferred. Certification a plus
- Required Experience: 5+ years of regulatory experience. Some portion may include relevant exposure to pharmaceutical or medical device regulatory work (e.g., other R&D role or specialized training).
- Requires drug development experience in US and Canada region. Proven 3-5 years in a leadership role with strong management skills.
- Experience working in a complex and matrix environment, and with multiple stakeholders.
- Experience interfacing with government regulatory agencies.
- Experience working with Health Authority Strong communication and proactive negotiation skills. Business acumen and able to work under pressure Preferred Experience: 7+ years’ experience in pharmaceutical regulatory activities; preferably in at least 2 regions/major countries.
- Experience developing and implementing successful global regulatory strategies. Strong clinical foundation preferred. Note: Higher education may compensate for years of experience
Significant Work Activities: N/A
Job Type: Experienced