Manager / Senior Manager, Regulatory Operations (IND, NDA) – NC BioPharma/Remote

Job Type: 
Other Life Science Positions
Regulatory Affairs and Medical Affairs
Life Sciences
Employment Category: 
Direct Hire

Our client, a rapidly-expanding Biopharma company in Research Triangle Park, NC, is actively recruiting for a highly skilled Regulatory Operations Manager to assume a key role on its R&D team.  Company will pay top dollar to attract and retain an excellent candidate.

This company which is publicly-held, is developing products in oncology and other severe disease states, has commercial product and has numerous compounds in development.  It is an exciting time and we seek an exceedingly capable Regulatory professional to drive all internal Regulatory Operations efforts.  Experience with IND and NDA submissions will be essential. 

Key Things to Note:

  • The company is headquartered in Research Triangle Park, NC and is open to office-based or home-based candidates in the US
  • The focus will be getting submission documents ready for handover to 3rd party publishing partners.  Ideal candidate will have experience collaborating with key third party vendors.
  • This is technical and highly regulated work.  Seek an expert in hyperlinking as well as FDA eCTD guidances.  Knowledge of IND and NDA document submission requirements and processes assumed and essential.
  • This is an emerging business setting.  Seek candidate who enjoys and will thrive in a “building” role.

The focus of this role will be to prepare IND and NDA submission documents for publishing. 

Specific duties will include:

  • Assist in making regulatory documents submission ready to ensure efficient handover of all components to third party publishing group
    • Includes performing the bookmarking and creating hypertext links following FDA eCTD guidance’s
    • Includes quality control of documents that already have bookmarks and hyperlinks to ensure they meet all FDA guidance’s
  • Assist in archiving of all submissions made to regulatory authorities in appropriate file share or document management system
  • Support in keeping up-to-date record of all correspondence with regulatory authorities
  • Contribute to performing quality control checks of submission documents/submissions as requested
  • Experience in tracking and storing documentation, including spreadsheet/database management

This is an emerging environment and employees are hands-on, flexible and mission-driven.  We seek a candidate whose industry credentials are complemented by the versatility, resourcefulness and commitment to thrive.

Requirements include a Bachelor’s degree in a scientific field  and 4 years of experience with Regulatory Operations, including substantial experience with IND and NDA submissions 

Other priorities include:

  • Knowledge of submission readiness and eCTD requirements
  • Knowledge of Study Data standards for INDs and NDAs
  • Knowledge of Promotional Materials Submissions
  • Proficient computer skills including MS Word, PowerPoint, Adobe, Excel, document processing/publishing skills
  • Ability to effectively manage multiple projects and complex timelines in a fast-paced team environment

This position has great potential.  We seek a natural point person and one who is ready and able to contribute. Longevity and record of impact in previous positions will all be important.

Please forward Word resume for prompt consideration.