Senior Regulatory Associate

Morton Grove, IL

Post Date: 12/05/2017 Job ID: 7903 Industry: Pharma Pay Rate: $85,000.00 - $90,000.00

RESPONSIBILITIES

    • Successfully build relationships with FDA s Center for Drug Evaluation and Research, Office of Generic Drugs through frequent contact and regular participation in teleconference and online meetings



    • Responsible for coordination between FDA and regulatory personnel of manufacturing and R&D



    • Responsible for Weekly/ monthly tracker



    • Constant follow up with FDA and keep a track of all the major goals and time lines



    • Responsible for regulatory project management functions, such as developing regulatory strategy for submission projects, delegating tasks and tracking progress / milestones against company goals



    • Regulatory responsibilities include review, publish, and post submission activities pertaining to ANDAs filed with FDA



    • Rapidly assume the role of U.S. Agent, if required



    • Anticipate obstacles and prepare with contingency plans so as not to impede the drive to the file and obtain ANDA approvals.



    • Must have experience within generic pharmaceutical industry, preference for solids, liquids, topical or solutions and suspension.



    • Work with RA Manager and senior staff to develop and implement regulatory compliance and submission strategies in support of business objectives.



    • Provide regulatory support to project teams and technical areas.



    • Support labeling, advertising, eCTD and other department programs as needed.



    • Maintain personal training and develop professional expertise.



    • Maintain existing approvals with timely and accurate reporting to FDA prepared under supervision.



    • Serve on project/regulatory submission teams providing clear and accurate regulatory guidance.



    • In cooperation with Manager, work to solve regulatory issues and enhance company reputation.



    • Communicate directly with government agencies to solve regulatory issues and enhance company reputation



    • Review, approve, submit, and file advertising and promotional materials in compliance with regulatory requirements



    • Knowledge of Code of Federal Regulation (21 CFR), US FDA Guidelines, US Pharmacopoeia, current Good Manufacturing Practices (cGMP) and Good Clinical Practice (GCP).





QUALIFICATIONS:

    • 5+ years experience in the pharmaceutical industry with well-known and respected firms



    • Advanced degree, preferably in a scientific/technical field



    • Minimum of 2-3 years of experience in interaction with FDA other regulatory agencies



    • Broad background and knowledge of FDA regulatory requirements and regulatory submissions



    • Well versed with eCTD for submission to various Regulatory agency



    • Proficiency in MS Office



    • Outstanding verbal and written communication and presentation skills



    • Ability to adapt to changes in the work environment; manage competing demands; and deal with frequent change, delays, or unexpected events.



    • Ability to maintain confidentiality







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