Allergan Sr Regulatory Affairs Analyst in Irvine, California
Sr Regulatory Affairs Analyst
Irvine, California, United States at https://agn.referrals.selectminds.com/jobs/7676/other-jobs-matching/location-only
Jan 09, 2019Post 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 Sr. Regulatory Affairs Analyst will ensure technical accuracy and regulatory compliance of all submissions for which they are responsible and ensures that applications are executed appropriately and submitted on time. He/ She will represent Regulatory Affairs for pharmaceutical development projects and marketed products. Working with manager, responsible for development and communication of global regulatory strategy on R&D project teams.
Main Areas of Responsibilities
Plans and prepares complex regulatory submission documents for US or OUS regulatory filings. Utilizing detailed, in-depth understanding of regulations for device products, leads and participates in global regulatory teams, interprets regulations, and provides regulatory guidance. Supports management with implementation of departmental strategies and policies.
The employee must conduct their work activities in compliance with all Allergan internal requirements and with all applicable regulatory requirements, including knowledge of operating in a controlled environment per the requirements of 21 CFR 820, ISO 13485 and ISO 14971. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
Submissions: Plans and prepares complex regulatory documents for US and potentially OUS submissions, under minimal supervision. Resolves submission problem areas with input from supervisor. Prepares clear and accurate internal and external complex administrative and scientific documents, under minimal supervision. Review of labeling and packaging components to ensure accuracy and compliance with government regulations
Advisory Responsibilities: Participates on global regulatory teams. Works with team to resolve complex project issues. Has recognized regulatory expertise and extensive knowledge of regulatory requirements and regulations with ability to strategically interpret and communicate requirements.
Communications: Maintains professional relationships with functional areas outside regulatory. Develops professional relationships with Health Authorities through supervised process. Interacts as appropriate with outside vendors, suppliers, contract research organizations, and others. Prepares documentation that is complete, accurate, and on time. Is responsible for distribution and filing.
Regulatory Compliance: Critically reviews complex reports, validations, etc. for scientific merit and regulatory appropriateness under limited supervision. Approves manufacturing process changes in consultation with supervisor, as appropriate. Interprets compliance regulations within the scope of departmental policy.
Supervisory Responsibilities: Performs peer review of complex regulatory documents. With input from supervisor, identifies and recommends solutions for problems identified. Assists in limited aspects of training for personnel and may supervise as appropriate.
Essential Skills and Abilities
Excellent interpersonal skills and supervisory potential.
Computer literate with excellent knowledge of Allergan systems for electronic storage and submission
In-depth knowledge of regulations
Good negotiation skills.
Education equivalent to a BS degree in a scientific field, plus six years’ experience in regulatory affairs; or
Education equivalent to a MS degree in a scientific field, plus four years’ experience in regulatory affairs; or
Education equivalent to a PhD degree in a scientific field, plus two years’ experience in regulatory affairs.
At least two years of medical device experience strongly desired.
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.