The Sr. Manager Regulatory Affairs represents US Regulatory Affairs for pharmaceutical development projects and marketed products. Working with manager, responsible for development and communication of global regulatory strategy on R&D project teams.
Ensures technical accuracy and regulatory compliance of all submissions for which they are responsible and ensures that applications are executed appropriately and submitted on time. Has authority to make decisions on US regulatory strategy and to submit complex submissions.
Directs communications and interactions with US FDA and other regulatory agencies as needed. Acts as primary contact for the US FDA.
Supports management with development of, and as appropriate, leads implementation of department strategies and policies.
- Represent Department at Global Project Team. Develop US regulatory strategic plan and provides guidance to GRL and project team. Represent US Regulatory on Global Regulatory Teams for assigned development projects and marketed products. Work with GRL/manager to resolve complex project issues. Utilize US regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained.
- Work with manager, set strategy for submissions of product registration documents to health authorities worldwide. Interact with other line functions in the preparation, review, and completion of documents for regulatory submissions. Will be responsible for US submissions (strategy and submission preparation).
- Will clearly articulate US regulatory strategy at Project and Regulatory Team meetings. Be able to negotiate with team to assure acceptance of regulatory strategy. Assures compliance with project team timelines and milestones.
- Work with manager, effectively plan, organize, and conduct 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. Act as primary contact for the US FDA.
- Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact Allergan Aesthetics’ products and operations. Advise personnel in other departments regarding their applicability and impact.
- Education equivalent to a PhD or MD degree or equivalent in a scientific field or experience in lieu of, plus at least 4 years’ experience in Regulatory Affairs; or
- Education equivalent to a MS degree or equivalent in a scientific field or experience in lieu of, plus at least 6 years’ experience in Regulatory Affairs; or
- Education equivalent to a BS degree or equivalent in a scientific field or experience in lieu of, plus at least 8 years’ experience in Regulatory Affairs;
- Analytical thinking and problem-solving skills
- Excellent communication skills, verbal and written.
- Excellent interpersonal skills and leadership potential.
- Computer literate with knowledge of EDMS systems for electronic storage and submission.
- Advanced knowledge of US and ICH regulations
- Excellent negotiation skills
Significant Work Activities: N/A
Job Type: Experienced