Regulatory Affairs Manager

2 days ago


Bridgewater, New Jersey, United States EUSA Pharma Full time
Job Title: Senior Manager, Regulatory Affairs

This is a challenging opportunity to join our team at Recordati Rare Diseases, Inc. (RRD), North America, an affiliate of Recordati.

We are seeking a highly skilled and experienced Senior Manager, Regulatory Affairs to lead our Regulatory Affairs Lifecycle Management team. The successful candidate will be responsible for managing the regulatory strategy for life cycle management in the US and Canada, including the preparation of regulatory submissions and interface with relevant health authorities.

Key Responsibilities:
  • Provide input to the regulatory strategy for life cycle management in the US and Canada
  • Implement regulatory strategies supporting lifecycle management for the US and Canada
  • Review documentation and prepare lifecycle management submissions
  • Liaise with regulatory authorities as needed pertaining to product lifecycle management
  • Oversee the submission of advertising and promotional material to the FDA as required
  • Support the labeling and/or change control processes to ensure timely and comprehensive review
  • Maintain labels/labeling for newly acquired and existing products in compliance with regulatory requirements and company standards
  • Track Annual Report and Periodic Safety Update Reports (PSUR) schedules to ensure that required dossiers are prepared and submitted as required
  • Coordinate with Medical Affairs & Pharmacovigilance to ensure timely reporting of safety data to regulatory agencies and partners
  • Ensure compliance with all federal regulations regarding post-marketing reporting to the FDA and other health authorities
  • Supervise and train direct reports as applicable
  • Act in full compliance with all laws, regulations, and policies including adverse events/pharmacovigilance responsibilities
Requirements:
  • Bachelor's degree required; advanced degree in the life sciences preferred
  • At least 12 years' experience in Regulatory Affairs, with managerial experience
  • Experience in a commercial-stage organization required
  • Demonstrated ability to deliver quality results within a fast-paced, dynamic environment
  • Knowledge of current FDA and Health Canada regulations and guidances; and knowledge of and experience with pharmacovigilance and related drug safety reporting regulations
  • Ability to manage multiple priorities and regulatory submissions at different stages as required
  • Strong project management skills with proven ability to drive projects through to completion
  • Working knowledge of Veeva platform helpful but not required
Work Environment:

This job operates in a professional office environment. The employee must be able to freely operate and travel by car and train/plane modes of transportation. A valid driver's license and means of transportation are required.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

This is largely a sedentary role; however, the employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; talk and hear.

Occasionally is required to lift and/or move light to moderate weight up to 25 lbs.

Location/Travel:

This position is located at RRD's US headquarters in New Jersey. Approximately 10% travel (domestic and international) is required.

This position is considered Exempt.

Recordati Rare Diseases is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to providing reasonable accommodations for qualified individuals with disabilities.



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