Allergan Manager, Regulatory Affairs in Irvine, California
Manager, Regulatory Affairs
Irvine, California, United States at http://agn.referrals.selectminds.com/jobs/346/other-jobs-matching/location-only
Aug 26, 2016Post 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 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.
The Manager, Regulatory Affairs supports the Global Regulatory Lead in the development and implementation of global regulatory strategy for development-stage pharmaceutical products.
Main Areas of Responsibilities
Serves as Global Regulatory Lead for mature products.
Manages, reviews, plans and prepares complex regulatory submission documents for global regulatory filings.
Interprets regulations and provides regulatory guidance to global regulatory teams.
Has authority to submit complex submissions and may act as primary Allergan contact with US FDA
May lead selected US FDA meetings.
Ensures technical accuracy and regulatory compliance of submissions.
May train and provide guidance to lower level staff.
In Regulatory Lead or supportive role, drives global regulatory strategy, advising on CMC, non-clinical and clinical development programs for assigned projects in line with business goals and objectives.
Provides regulatory affairs perspective to project teams and other functions.
Supports management with development and implementation of departmental strategies and policies
Will have responsibility to work in one or more therapeutic areas, covering multiple development projects.
Primary product responsibility will be in the Neurology, Urology, and/or Dermatology therapeutic areas.
The following listed requirements need to be met at a minimum level to be considered for the job:
Experience in regulatory affairs
Analytical thinking and problem solving skills
Exceptional communication skills, verbal and written.
Excellent interpersonal skills and leadership potential.
Computer literate with in-depth knowledge of Allergan systems for electronic storage and submission.
Excellent negotiation skills.
BS in a scientific field, plus seven years experience in regulatory affairs; or
MS in a scientific field, plus five years experience in regulatory affairs; or
PhD in a scientific field, plus two years experience in regulatory affairs.