Allergan Dir Sr Regulatory Affairs - CMC in Irvine, California
Dir Sr Regulatory Affairs - CMC
Irvine, California, United States at http://agn.referrals.selectminds.com/jobs/630/other-jobs-matching/location-only
Sep 22, 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.
Oursuccess 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.
Join our bold team! Learn more at www.Allergan.com at http://www.allergan.com/ .
This position will provide leadership within the Global Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) organization by actively contributing to and managing staff that development and implement global regulatory CMC strategies for post-approval changes for of biologics, pharmaceuticals, and/or device marketed products. Key day-to-day activities will include the preparation of CMC 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. The Sr. Director will also be responsible for the oversight of developing and implementing global regulatory strategies for investigational product registrations and leads efforts to achieve successful product registrations in accordance with business objectives, identifies areas of business risk and develops risk mitigation strategies. The position will require international experience.
Main Areas of Responsibilities
Guide, direct, and lead a team of regulatory professionals in the development of strategic plans and regulatory submissions for approval of investigational products and post approval changes for marketed products.
Identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.
Foster and maintain relationships with regulatory authorities to facilitate interactions on behalf of Allergan. Act as primary contact with the regulatory authorities for CMC meetings including the planning and leadership of meetings
Oversee development and negotiation of overall plans regarding quality to assure viability for global or regional registrations. Must understand international regulations and be able to implement corporate standards across all regions. Ensure alignment of regulatory strategy to business strategy across all functional areas.
Accountable for ensuring that all relevant regulatory submissions meet appropriate standards and content requirements, including planning and implementation around emerging/changing regulatory requirements.
Develop and manage budget, responsible for training, mentoring and professional development of junior level regulatory professionals, develops, reviews and approves departmental procedures, policies, and guidelines, including the preparation and maintenance of regulatory SOP’s to support Global Regulatory Quality System requirements
As regulatory representative on cross functional product teams, applies advanced knowledge of regulations and interprets technical regulatory guidelines to ensure that regulatory submissions are in compliance with government regulations
Interprets new regulatory policies and trends and as they apply to company products and procedures for impact and/or potential change in approach
Minimum of 10 years’ experience in RA including at least 7 years experience managing people. International experience/exposure preferred.
Must have comprehensive understanding and applied knowledge of regulatory requirements including FDA, EMEA, ICH guidelines and regulations as they apply to registration, development and approval of investigational products and post approval changes for marketed products, with an emphasis on CMC regulation of biotech/biological products.
Comprehensive knowledge of the drug development process and experience in domestic and international product registrations (i.e, IND, CTA, BLA, NDA, NDS, MAA)
Excellent written and verbal communication, presentation, negotiation and facilitation skills
Expert knowledge of quality regulations, current industry practices, and strong experience with interpretation and application
Sound basis of Scientific (Training/Communications) knowledge
Strong negotiation skills and significant experience in interacting with regulatory authorities
Knowledge, experience with use of relevant industry available regulatory software
Risk management and problem solving skills
Demonstrated ability to lead, mentor, and develop others for future growth and development
Established relationships with regulatory authorities
Extensive familiarity with Industry and knowledge of forces impacting function
Ability to travel
BS, MA or PhD (preferred) in related scientific discipline