Regulatory Affairs Director

 

A growing specialty a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health has engaged Junto HLS to recruit a Regulatory Affairs Director.

Description: The Regulatory Director provides regulatory expertise and support for pre-clinical, clinical, and commercial areas for investigational and marketed products. Ensures developments of drugs are in accordance with global regulations in order to approve drugs quickly and smoothly within typical approval timeframes. Ensures marketed products are supported with minimal questions and issues from the regulatory agencies. Establishes well-defined regulatory pathways and creates accurate and timely documents for IND and NDA submission and final approval.

Select Accountabilities:

  • Provides strategic regulatory leadership and guidance to the project teams. Designs programs for complete and accurate IND/CTA submissions and ensures that clinical trials are designed to meet regulatory requirements.
  • Provides regulatory expertise and support for nonclinical, clinical, and commercial areas for investigational and marketed products. Ensures developments of   drugs are in accordance with global regulations in order to approve drugs quickly and smoothly within typical approval timeframes. Ensures marketed products are supported with minimal questions and issues from the regulatory agencies. Establishes well-defined regulatory pathways and creates accurate and timely documents for IND and NDA submission and final approval.
  • Provides strategic regulatory leadership and guidance to the project teams. Designs programs for complete and accurate IND/CTA submissions and ensures that   clinical trials are designed to meet regulatory requirements.
  • Defines regulatory expectations for teams, identifies elements of INDs and FDA required preparation (and other Health Authorities in collaboration with regional regulatory affairs), positions response to regulatory agencies, defines strategy for negotiations and formal document submission, and provides strategic input in the development of the plan.
  • Interacts with regulatory agencies and ensures conversations and communications are focused, amicable and documented.
  • Oversees the submission of product registration of new drugs, progress reports, supplements, amendments, and periodic adverse experience reports. Develops strategies, drafts responses, and/or reviews responses and documents intended for submission to FDA to assure compliance with regulatory standards.
  • Oversee the review of documents/reports generated by RA support staff or contractors or other project team members to assess the likelihood that the content will meet pre-specified objectives, and provides input towards this end.
  • Responsible for management, monitoring, oversight, strategic development, and global labeling approvals.
  • Recruits, trains, and coaches staff; evaluates employee performance on an ongoing basis, and completes annual performance reviews as appropriate.

Location(s):

  • Bedminster, NJ

If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.