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Regulatory Affairs Manager JD816684

JD816684

DPS is looking for a knowledgeable Regulatory Affairs professional to work with a BioPharma client in the Boston, MA area. The ideal candidate will have strong expertise around regulatory affairs and must be able to work on their own initiative with an understanding around what they need to do. The position will involve leading negotiations/communications around timelines for filing with FDA/EMEA as well as managing the compilation process for regulatory dossiers in order to obtain manufacturing licenses. It is essential that the selected candidate possesses excellent verbal and written communication skills and is able to communicate to leadership at very senior levels within the organization.

Category:
Miscellaneous Personnel
Location:
Massachusetts
Years of Experience Req.:
7+
Date Posted:
15/07/2020
Days Remaining:
7
Employment Type:
Full-time
Education Level Req.:
Bachelors Preferred

Regulatory Affairs Manager              JD816684

Boston, MA area

 

Summary:

DPS is looking for a knowledgeable Regulatory Affairs professional to work with a BioPharma client in the Boston, MA area. The ideal candidate will have strong expertise around regulatory affairs and must be able to work on their own initiative with an understanding around what they need to do. The position will involve leading negotiations/communications around timelines for filing with FDA/EMEA as well as managing the compilation process for regulatory dossiers in order to obtain manufacturing licenses. It is essential that the selected candidate possesses excellent verbal and written communication skills and is able to communicate to leadership at very senior levels within the organiz40810.9014421ation.

 

Responsibilities:

  • Supports execution of global registration and clinical development strategies for all pipeline products and support activities.
  • Responsible for preparation/submission/maintenance of current and future MAA and IND/IMPD (including variations, amendments, annual reassessment) and Scientific Advice and FDA meetings for all of products and support activities.
  • Maintain regulatory files and records of contact with Regulatory Authorities.
  • Advise all clinical-related and CMC-related departments (Clinical Operations, Process Development, Analytical Development, Manufacturing and Quality Control) on the preparation and content of IMPDs, INDs and MAA dossiers to ensure timely delivery of final documents to be included in submissions.
  • Support close regulatory interactions globally throughout the lifecycle of pipeline projects to secure the development of appropriate development plans, Pediatric Investigational Plans (PIPs) and registration strategies, etc.
  • Assist in the global submissions for early and pivotal clinical studies to support regulatory approvals.
  • Review promotional, advertising, and labeling items.
  • Maintain an up-to-date knowledge of the relevant (EU, US and ICH) regulations, pharmacopoeias, guidelines and gain regulatory intelligence by visiting relevant meetings and conferences. 

 

Skills and Experience:

Bachelor’s degree or equivalent is required.

  • 7+ years of Regulatory Affairs experience within the biotech/pharmaceutical industry in both the pre-market and post-market setting.
  • Experience in biologics/vaccines/gene therapeutics/fill finish is preferred.
  • Experience with international regulatory submissions and an understanding of worldwide drug and biologics guidelines and regulations.
  • Demonstrated people management experience.
  • Excellent oral and written communication skills.
  • Must be able to communicate vertically and horiz40810.9014421ontally within an organiz40810.9014421ation.
  • Respectful and collaborative team player with both line and matrix management experience.
  • Record of influencing project teams, strategically, operationally and delivering on budget and within agreed upon timelines.
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