Sr. Regulatory Affairs Specialist / Manager
at The Franklin Company

Date Posted: 6/24/2017

Job Description

Sr. Regulatory Affairs Specialist / Manager 
Permanent Position
Salary Open to Negotiation based on Industry Salary Ranges

Position Purpose:

The Sr. Regulatory Affairs Specialist/Manager is responsible for regulatory submissions and maintaining submission information in a proper RA system. The incumbent works cross-functionally with internal departments and external resources on source documents and Regulatory related issues, ensuring those are in compliance with FDA regulations and company SOPs. The incumbent is also responsible for preparation of labeling and artwork, eCTD compilation and submission for ANDAs and NDAs registration and maintenance.

Specific Duties and Responsibilities: 

Regulatory Submissions:

  • Works cross-functionally with internal departments and external resources (e.g., CROs, CMOs) to ensure that source documents are received in a timely manner for submissions.
  • Prepares original ANDAs and NDAs, amendments ensuring these are in compliance with applicable FDA regulations.
  • Performs documents formatting and publishing to ensure that submission documents adhere to FDA eCTD requirements and company SOPs.
  • Has responsibility for archiving of all original submissions in a secure system and maintains and keeps an up-to-date record of all correspondence with FDA.

Labeling and Artwork:

  • Works cross-functionally with internal departments and external resources to ensure that labeling and artwork are received, reviewed and approved in a timely manner for submissions.
  • Prepares contents of labeling for new registration and/or revised labeling of drug products in accordance with RLD and applicable FDA regulations (e.g., 21 CFR 201 and 208).
  • Proofreads, reviews and approves labeling printer proofs to ensure accuracy of contents, completeness and integrity.
  • Monitors RLD labeling updates and initiates change requests, if necessary, for labeling of all new registration and marketed products in accordance with RLD.

Job Snapshot

About Us

Let us find you the perfect placement! The Franklin Company is a leading provider of contract temporary services throughout the United States. We connect Managers, Engineers, Administrators, Designers, Scientists, Chemists, Biologists, and Technicians with local, regional, and Fortune 500 companies.

Our client list includes many of the most notable and innovative companies across the country. When you partner with The Franklin Company you can expect assignments that will challenge you and develop your career skills as well as compensation that matches your education and experience.

At The Franklin Company, we are here for you! Enjoy direct access to staff with answers about benefits, special payroll considerations, retirement options, and support with day-to-day workplace issues. Whether you are interested in temporary, temporary to permanent, or permanent placement services, we will find you a great opportunity that matches your skills and career goals.

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