Vice President Regulatory Affairs
This leading U.S pharmaceutical organisation with corporate headquarters in Ireland is a company focused on the treatment of obesity and obesity related medical problems. This organisation’s first medicine was approved in the United States in September 2014 and has become the most prescribed branded obesity medication since June 2015. In Europe, the drug has been approved under a separate brand name and this business is now undertaking a range of commercialisation activities, both on their own and with key strategic partners, to bring these innovative products to patients around the world.
- Provide global regulatory strategic leadership supporting commercialisation and post-marketing activities and requirements for approved products in US, Europe, and other global regions.
- Manage an international team of Regulatory staff including senior directors, manager-level staff, and several consultants.
- Design regulatory strategies and build a stage-appropriate team to support business decisions, product applications and claims, from development through product lifecycle management.
- Keep peers and superiors apprised of expected changes to the regulatory landscape affecting existing and future Company products and provide strategic and tactical direction to drive cross-discipline consistency in regulatory approach and planning.
- Facilitate best strategy for clearance/approval of products in rest-of-world regions either by the company or by its partners/affiliates and act as senior regulatory contact for ongoing alliance management functions.
- Act as primary strategic contact with the FDA, EMA and other regulatory agencies to enable execution of company regulatory goals.
- Develop and design robust regulatory structures, processes and procedures and budget forecasting based on expert understanding, industry experience, and insight into future direction.
- Support Medical Affairs, Pharmacovigilance and Safety functions as an active member of the Safety governance and review team.
- Provide guidance to business development regarding critical evaluation of potential product opportunities, including drugs, biologics, and devices supporting strategic partnering and licensing activities.
- Develop and plan innovative regulatory strategies for label enhancements and life cycle product management.
- Provide regulatory review and approval of product labelling, promotional claims and advertising to ensure compliance with corporate policy, US and international laws and regulations.
- The ideal candidate will possess at least 15 years of experience leading Regulatory Affairs within the pharmaceutical industry with 7 years of specific leadership and management experience. An advanced degree is ideal.
- Experience leading this function, specifically the designing, writing, and submission of regulatory filings and correspondence within a similarly complex specialty/branded commercial pharmaceutical organisation, is required.
To learn more, apply on line or call Shane Browne at HRM on +353 1 6321865.
Salary: On Application
Location: Dublin City Centre