Allergan Mgr, Regulatory Affairs - Women's Health in Jersey City, New Jersey

Mgr, Regulatory Affairs - Women's Health

Jersey City, New Jersey, United States at

6 days agoPost Date

151704Requisition #

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 pharmaceuticals and biologic products for patients around the world. Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular 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. Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.

Join one of the world’s fastest growing pharmaceutical companies!

At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.

Position Description

This position will provide leadership within the Allergan Women's Health Division. Key day-to-day activities will include the preparation of regulatory submissions that meet global regulatory requirements, attending project teams or oversight committees, and representing the company during communications and meetings with health authorities. Additional responsibilities may include representing Allergan at industry meetings.

Main Areas of Responsibilities

· Independently lead global regulatory strategy development, planning, and implementation for multiple complex programs and platforms. Participate in identification of risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans

· Guide and influence technical groups in areas of product development and lifecycle enhancement. Participate in potential and established third party efforts (i.e. Due diligence activities, joint ventures, etc)

· Initiate and maintain appropriate communication within the RA function and represent Regulatory Affairs with business units and other functions. Implement policies to ensure ongoing compliance of regulatory requirements.

· Develop and implement regulatory strategy aligned with business strategy. Assess impact of new regulations and implement appropriate changes as well as lead development of company policy and positions on draft regulation and guidance

· Responsible for negotiating and decision making with regulators and stakeholders with complex and high-risk projects.

· Provide direct or indirect supervision of individuals including mentoring, performance management and staffing decisions.

· Represent Allergan externally at appropriate industry associations. May act as primary contact with regulatory authorities including the planning and leadership of meetings. May participate in management of budgets


· Sound basis of Scientific (Training/Communications) knowledge in multiple areas

· Expert knowledge of regulations, and experience with interpretation and application

· Excellent written and verbal communication, presentation, and facilitation skills

· Strong negotiation skills and significant experience in interacting with regulatory authorities

· Risk identification and problem solving skills

· Demonstrated ability to lead, mentor, and develop others for future growth and development;

· Established relationships with regulatory authorities

· Ability to travel

Preferred Skills/Qualification

· Experience in a pharmaceutical manufacturing facility/development laboratory will be an advantage.


· B.S. required in related scientific discipline with a minimum of 6 years’ experience in RA, including managing people or projects. Or, MS degree and 4 years’ experience or PhD and 2 years of experience.