Allergan Assoc Dir, Regulatory Affairs in Jersey City, New Jersey
Assoc Dir, Regulatory Affairs
Jersey City, New Jersey, United States at http://agn.referrals.selectminds.com/jobs/735/other-jobs-matching/location-only
Jan 03, 2017Post 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.
In collaboration with others and under regulatory supervision, the incumbent coordinates, prepares, reviews, and submits regulatory filings to the Food and Drug Administration (FDA) and other regulatory health authorities in accordance with applicable regulations and guidelines. The individual will be responsible for coordinating, preparing and submitting NDA, ANDA, and IND annual reports, periodic safety filings, labeling updates, and other miscellaneous regulatory submissions. The individual will be responsible for assisting with the preparation of NDAs and NDA supplements.
· Carries out responsibilities in accordance with the Allergan’s policies, procedures, and work instructions, as well as with federal, state, and local laws.
· Drafts and prepares annual reports, including obtaining necessary components and making a determinations of content for review and approval by the manager or the manager’s delegate.
· Creates various sections of NDAs, ANDAs, INDs, amendments, and supplements for review and approval by the manager or the manager’s delegate.
· Collaborates with the regulatory publishing staff in the preparation, assembly, compilation and publication of regulatory submissions in electronic (eCTD) or other format, as required.
· Evaluates and researches any submission deficiencies, additional information or testing as requested by regulatory authorities.
· Participates in team and problem solving activities for assigned projects.
· Ensures project deadlines and performance standards are established and met.
· Interacts with regulatory authorities on assigned projects to identify and resolve any issues with regulatory filings and to monitor the status of regulatory filings.
· Communicate application progress to internal stakeholders
· Updates regulatory databases and spreadsheets as assigned with accurate and up-to-date information about regulatory applications.
· Assists as needed with maintaining annual licenses, registrations, listings and patent information
· Remains in compliance with all company policies and procedures, including safety rules and regulations.
MS degree in life science or related field with 8+ years of experience in biomedical research activities, or BS degree with 10+ years of experience of which at least 3 years must include a proven record in local/global regulatory affairs.
An advanced technical degree (Ph.D., M.D., D.V.M., or Pharm.D.) in life sciences with 7 + years direct experience in biomedical research along with In-depth knowledge of clinical trial methodology and clinical auditing procedures. 5 years in local/global regulatory affairs strategy.
Leadership role with major U.S. regulatory submissions (e.g., NDA, sNDA, IND), including maintenance activity
FDA direct experience
Experience with global clinical trial applications (CTA)
Phase 2/3 program level experience
Required Knowledge and Skills
· Current FDA/Regulatory Affairs submission requirements including those in eCTD format.
· Logistics and work of the pharmaceutical industry.
· Business and personal computer hardware and software applications.
· Business English usage, spelling, grammar and punctuation.
· Current Company policies, practices and procedures, including safety rules and regulations.
· Compiling and preparing routine regulatory submissions for FDA
· Responding to routine inquiries from management, employees and regulatory agencies.
· Communicating clearly and concisely, both orally and in writing.
· Operating scientific and personal computers.
· Planning, managing, and tracking multiple projects, duties and assignments.
· Applying Federal, state and local policies, procedures, laws and regulations.
· Establishing and maintaining cooperative working relationships with others.
· Ensuring personal compliance with all company policies and procedures, including safety rules and regulations.