Dir, Regulatory Affairs (Reg. Strategy)Allergan, Inc - Madison, NJ
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. Position Overview 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 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.
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.
Requirements 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) Preferred Skills/Qualification 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 Education Bachelor’s degree required; Advanced life science degree preferred. *LI-DM1
7 days 18 hours ago
applyDir, Regulatory Affairs (Reg. Strategy) Allergan, Inc - Madison, NJ, United States
Allergan, Inc. operates as a multi-specialty health care company primarily in the United States, Europe, Latin America, and the Asia Pacific. The company discovers, develops, and commercializes pharmaceutical, biological, medical device, and over-the-counter products for the ophthalmic, neurological, medical aesthetics, medical dermatology, breast aesthetics, urological, and other specialty markets. It operates in two segments, Specialty Pharmaceuticals and Medical Devices. The Specialty Pharmaceuticals segment produces a range of pharmaceutical products, including ophthalmic products for dry eye, glaucoma, inflammation, infection, allergy, and retinal disease; Botox for certain therapeutic and aesthetic indications; skin care products for acne, psoriasis, eyelash growth, and other prescription and physician-dispensed skin care products; and urologics products. The Medical Devices segment offers a range of medical devices, such as breast implants for augmentation, revision, and reconstructive surgery, as well as tissue expanders; and facial aesthetics products. The company sells its products to drug wholesalers, independent and chain drug stores, pharmacies, commercial optical chains, opticians, mass merchandisers, food stores, hospitals, group purchasing organizations, integrated direct hospital networks, ambulatory surgery centers, government purchasing agencies, and medical practitioners. It focuses on eye care professionals, neurologists, physiatrists, dermatologists, plastic and reconstructive surgeons, aesthetic specialty physicians, urologists, urogynecologists, and general practitioners. The company has collaboration agreements with Molecular Partners AG; Spectrum Pharmaceuticals, Inc.; and Serenity Pharmaceuticals, LLC. Allergan, Inc. was founded in 1948 and is headquartered in Irvine, California.
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