Allergan Regulatory Affairs Manager, Strategy in Madison, New Jersey
Regulatory Affairs Manager, Strategy
Madison, New Jersey, United States at https://agn.referrals.selectminds.com/jobs/6282/other-jobs-matching/location-only
Aug 20, 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 role of the Regulatory Affairs Manager is to develop the corporate regulatory submission strategy and provide regulatory guidance and strategic assessments to project teams for assigned products. Additional responsibility includes the preparation and management of regulatory submissions, and contribute as a liaison with internal staff, business partners, and regulatory authorities to identify and manage initiatives to improve department capabilities.
Main Areas of Responsibilities
Develop regulatory submission strategy for assigned products. Interact with project team members to define submission logistics and scheduling. Coordinate priorities for major milestones in product lifecycle, including submissions, labeling, safety information, approval and registration strategy for FDA/health authorities.
Coordinate/manage/maintain routine submissions (ex. protocol amendments, annual reports, investigator submissions, safety reports) for assigned products. Actively monitor and advise applicable team members and product managers of upcoming regulatory deadlines and other critical dates (ex. patent expiration). Prepare submission packages and on approval, submit materials to applicable agencies.
May serve as the primary point of contact with the FDA for assigned products. Assemble and lead teams to develop response strategy to address FDA submission responses, inquiries, and information requests.
Provide leadership and planning for meetings with FDA/health authorities. Provide regulatory strategic input for assembly of briefing books, speaker selection, slide preparation, and meeting rehearsals.
Contribute regulatory perspective to cross-functional teams (including senior management) on due diligence evaluations of potential acquisitions and partnerships.
Maintain current knowledge of regulatory environment through reading and participation at professional seminars and workshops. Monitor health authority decisions, regulations, and guidances and interpret essential elements for impact on strategic regulatory decisions. Continually monitor competitor products and their submission outcomes for potential impact on the regulatory strategy.
Ensure that all regulatory documents are prepared in accordance with regulatory guidelines and internal standards and SOPs. Review and approve clinical drug shipment documents for shipment approval. Identify areas for improvement within daily functions, internal procedures, and regulatory agency interaction and contribute to improvement of these processes.
Knowledge of relevant pharmaceutical regulatory procedures and reporting requirements
Document management system knowledge is helpful
eCTD submission viewer experience is helpful
Strong technical background including proficiency in Microsoft Word, Microsoft Excel, Microsoft Powerpoint, Microsoft Outlook and Documentum
Oral and Written communication
Planning and Organizing
Decision Making, Judgment, and Problem Solving
People Relationships, Team Building, Motivating Employees, and Influencing Others
Initiative and Accountability
Promoting Innovation and Process Improvement
Willing team player capable of working collaboratively with colleagues in their department and in all functions
Energetic, self-motivated, organized individual who is accustomed to working in deadline-focused, high-pressure entrepreneurial environment.
3-5 years of pharmaceutical experience in Regulatory Affairs
Experience with IND and NDA submissions is helpful
Regulatory Affairs Certification (RAC) a plus
Bachelor’s degree required
Advanced degree preferred with major/concentration in life sciences, legal, or communications
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.