Allergan Sr Mgr, Regulatory Affairs in Irvine, California
Sr Mgr, Regulatory Affairs
Irvine, California, United States at https://agn.referrals.selectminds.com/jobs/6941/other-jobs-matching/location-only
Oct 09, 2018Post Date
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.
The Sr. Manager will represent 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.
Main Areas of Responsibilities
The Sr. Manager Regulatory Affairs will ensure 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 regulatory strategy and to submit complex submissions. Directs communications and interactions with US FDA and other regulatory agencies worldwide. Acts as primary contact for the US FDA. Supports management with development of, and as appropriate, leads implementation of department strategies and policies.
Advisory Responsibilities :
Represents Department at Global Project Team. Develops regulatory strategic plan and provides guidance to project team. Leads Global Regulatory Team for assigned development projects and marketed products. Works with manager 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.
Project Execution :
Working with manager, 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. Responsible for US submissions (strategy and submission preparation).
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:
Working 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. Acts as primary contact for the US FDA.
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.
· 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.
· Ability to influence without authority
· Education equivalent to a PhD or MD degree or equivalent in a scientific field, plus at least 4 years’ experience in Regulatory Affairs; or
· Education equivalent to a MS degree or equivalent in a scientific field, plus at least 6 years’ experience in Regulatory Affairs; or
· Education equivalent to a BS degree or equivalent in a scientific field, plus at least 8 years’ experience in Regulatory Affairs.
Equal Employment Opportunity Employer
Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.