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Manager, Regulatory Affairs at Amneal Pharmceutical of New York LLC in Piscataway, New Jersey

Posted in Science 30+ days ago.

Type: Full-Time

Job Description:

Reporting to the Director, Regulatory Affairs Clinical, the Manager, Regulatory Affairs, is a critical role within the Regulatory Affairs, Clinical organization. Responsibilities include conducting regulatory reviews of materials related to labeling, advertising and promotion of drug and generic drug products. The manager also serves as the permanent member of the Promotional Review Committee (PRC). 

Essential Functions:

  • Serves as the permanent regulatory representative on the Promotional Review Committee (PRC) 

  • Utilizing the Veeva Vault system, conducts regulatory review of materials related to labeling, advertising and promotion of brand and generic drug products

  • Provides relevant comments on advertising/promotional materials as well as final approval/disapproval

  • Supports compliance with internal SOPs and FDA requirements, including compilation and submission of any required documents to regulatory agencies.

  • Maintains up-to-date knowledge of laws, regulations and policies enforced by the FDA. as they relate to labeling, advertising and promotion of pharmaceuticals and provides regulatory advice accordingly.

  • Monitors impact of changing regulations on submission strategies and updates internal stakeholders accordingly. 

  • Communicates with consultants, attorneys and external parties as needed.

  • OPDP submissions (Form FDA 2253

Additional Responsibilities:

  • Compilation of cover letters, submissions and regulatory communications 

  • Management of submission timelines

  • Tracking of recurring regulatory activities

  • Routine monitoring of regulatory intelligence


  • Master Degree (MS/MA) Science, Technical - Preferred

  • Bachelors Degree (BA/BS) Science, Technical - Required


  • 4 years or more promotional review of drug products


  • Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment are required. -

  • Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects. -

  • Excellent written and verbal communication skills and interpersonal skills. -

  • Ability to communicate effectively and collaboratively as part of a team -

  • Ability to interface with professionals domestically and abroad. -

  • Ability to work independently, self-starter. -

  • Good problem-solving skills and analytical ability. -

Specialized Knowledge:

  • Prior promotional review experience

  • Knowledge of relevant FDA regulations.

  • Strong computer skills Experience in MS Word, Excel, Outlook and Adobe Acrobat

  • Working knowledge and experience with 21 CFR


  • RAPS certification --Preferred