Menu
Associate Director/Director, Regulatory Affairs

Associate Director/Director, Regulatory Affairs

The Associate Director/Director, leads the submission related activities associated with the US filings for the approved product lines in collaboration with the VP Regulatory Affairs. These responsibilities must take into consideration strategic alliance partnerships and ensure team alignment and strategies are vetted and approved across the organizations. The position will also ensure timelines are appropriately managed and kept to, and issues are appropriately raised and resolved in a timely manner. This person may participate in departmental work streams designed to improve development cycle timelines or to improve regulatory processes.

This position is in our Raleigh, NC office. 
 

Minimum Qualifications:

BSc Life Sciences in a relevant field with 10 or more years of regulatory experience and/or

Master's Degree with a minimum 8 years of regulatory experience. 

Regulatory experience required.

  • Experience interacting with the FDA.
  • Experience with Promotional Material Review.
  • Experience developing regulatory strategies in coordination with clinical plans and marketing objectives.
  • Experience in successfully leading teams and the ability to broadly represent RA functions on project teams.
  • Demonstrated matrix leadership skills and the ability to work effectively in a matrix team across multiple disciplines.
  • Working knowledge of relevant drug laws, regulations and guidance's/guidelines.
  • Travel of up to 10% may be required. 

 

Principal Responsibilities:

Regulatory Strategy
Contributes to the development of US regulatory strategies for commercial products and as required development products.

Identifies, monitors and resolves regulatory issues and reports progress to management.

Regulatory Submissions (INDs/NDAs)
Monitors regulatory submission activities and reviews regulatory documents prior to submission to ensure overall quality, compliance and timeliness. 

Partners with project teams to assess regulatory support needs and aligns resources to provide regulatory support. 

Interfacing with Authorities
Acts as the point of contact with regulatory authorities for assigned products.

Leads calls and meetings with regulatory authorities.

Compliance
Complies with applicable laws / regulations.

Demonstrates high ethical behavior at all times.

Life Cycle Management
Leading the planning, execution and assessment of product life cycle management activities and strategies for all assigned products.

Labeling and Promotional Material Review

Is a member of the Promotional review committee  and ensures all materials are consistent with FDA advertising and labeling regulations and guidance (e.g., fair balance, adequate substantiation of evidence, consistency with approved labeling and not false or misleading) and other regulatory enforcement trends, and OPDP guidance, such as OPDP enforcement letters, as well as consistency with any OPDP advisory comments, and advises on enforcement trends. 

Submits final promotional materials to OPDP on or before first use (Form 2253 submission).

Serves as the primary contact with the FDA Office of Prescription drug Promotion (OPDP) for assigned products.

Advises on the development of product and disease state communication materials across multiple functional areas: including Corporate Communications, Health Economics and Outcomes Research, and Medical Affairs.

 

If you are interested in applying for an Open Position, please follow the directions below: 

  1. Submit your resume to redhillemployment@redhillus.com

  2. In the subject line put the full job title of the position you are applying for (including city), your name and the date of your submission. Note that we will only consider applicants that specify the Open Position that they are applying for.

  3. Cover letters are optional.


We offer a Comprehensive Benefits package that includes:

  • Medical, Dental, and Vision Coverage
  • Domestic Partner Coverage
  • Life Insurance
  • Short-Term and Long-Term Disability
  • Flexible Spending Accounts (Healthcare and Dependent Care)
  • Employee Assistance Plan
  • 401(k)

Job Applicants should be aware of job offer scams that are committed though the use of the internet and social media platforms. All legitimate correspondence from a RedHill Biopharma employee will come from a “@redhillus.com” or “@redhillbio.com” email address.