Regulatory Affairs Associate at Somerset

Job Description

Job Classification: Contract Our client, a developer, manufacturer and marketer of high-quality, targeted, generic prescription pharmaceuticals across a variety of dosage forms and therapeutic categories is seeking a Regulatory Affairs Associate to Compile, review and transmit eCTD submissions to FDA and Demonstrate solid teamwork with RA team members; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality eCTD submission information to support company goals and objectives.Responsibilities include:-Review acceptability and compile eCTD submissions to support development and marketed products to ensure timely electronic submission transmission to FDA (Original Applications, Amendments, Supplements, Annual Reports and Drug Listings). -Establish GDUFA Self-Identification processes and maintain annual notification and updates. -Assist in the preparation and review of labeling and promotional materials for submission to regulatory agency.-Maintain and improve working knowledge of current and pending regulations and guidances for generic drugs to ensure compliance with Regulatory agency requirements.-Participate in the development and maintenance of Regulatory Operations systems, processes, checklists and procedures to facilitate consistency.-Organize and maintain Regulatory application records and indices in the Regulatory Operation Center.-Assist in the preparation of Annual Reports as needed. Join Aerotek Scientific®LLC, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, were constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know its more than just your day-to-day responsibilities that can make or break a job. Its the support you get. Thats the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Dont put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law.

Job Requirements

• Bachelors degree in chemistry, biology or other related scientific discipline required., 1-3 years in the pharmaceutical industry with 1 years of Regulatory experience supporting US FDA pharmaceutical products., Proficiency in eCTD Publishing Software (e.g. MedXview)., Exhibits knowledge of current FDA regulations and guidance related to regulatory product submissions, approval process, and maintenance of ANDAs and GDUFA Self-identification., Strong publishing and eCTD submission experience required.

Country: USA, State: New Jersey, City: Somerset, Company: Aerotek.