Collegium Pharmaceutical
Director of Regulatory Affairs
Stoughton, MA
May 12, 2025
Full-time
Full Job Description

Job responsibilities:

  • Develop regulatory strategies integrated with cross functional project teams and external stakeholders to facilitate timely subscriptions and approvals for post market regulatory submissions.
  • Author regulatory documents including cover letters, briefing documents, annual reports and labeling including package inserts and artwork, under minimal supervision and serve as inhouse regulatory expert to internal and external stakeholders.
  • Manage the label management process for all Collegium portfolio products including managing the approval of label changes and implementing revised labels and artwork with labeling vendors.
  • Review and approve change controls to determine the level of change and consequent submission requirements, assess potential impact on business objectives, and communicate impact accordingly to stakeholders in CMC, Manufacturing, and Technical Operations.
  • Provide Regulatory Expertise and serve as internal consultant on relevant US regulations and guidelines, current regulatory environment, and regulatory precedent.
  • Develop and maintain relationships with the FDA and lead the preparation of agency interactions as the main liaison between the company and the FDA Project Manager.
  • Handle urgent matters that arise from FDA information requests, offer regulatory counsel to stakeholders in Clinical, CMC and Medical, and reach well thought-out strategies to address regulatory matters for which there may not precise or clear regulatory guidance available from FDA.
  • Write and revise regulatory affairs standard operating procedures (SOPs), policies, and work instructions to ensure compliance and consistency for department processes.
  • Plan regulatory submissions to maintain INDs, NDAs, advertising and promotional pieces, and to address annual and periodic regulatory commitments.
  • Train and mentor junior regulatory affairs staff on the processes and systems used to manage all aspects of the department deliverables. 

Requirements:

  • Masters Degree in Regulatory Affairs

Applicants are to send Resumes to: Director, Talent Acquisition, Nick Zweig at hr@collegiumpharma.com

 

Job Information
Job Category:
Pharmaceutical
Spotlight Employer
Related jobs
Comcast
Comcast brings together the best in media and technology. We drive innovation to create the world's best entertainment and online experiences. As a Fortune 50 leader, we set the pace in a variety of i...
Jun 16, 2025
West Hartford, CT
Baylor Scott & White Health
Pharmacist (Inpatient)
Baylor Scott & White Health
About Us0- Overnight 7on/ 7off We believe that all people should feel welcomed, valued and supported, and that our workforce should be reflective of the communities we serve. Here at Baylor Scott & Wh...
Jun 16, 2025
Fort Worth, TX
Baylor Scott & White Health
Interventional Rad Tech PRN
Baylor Scott & White Health
LOCATION: BAYLOR SCOTT & WHITE MEDICAL CENTER, MARBLE FALLS, TX DEPT: CATH LAB SCHEDULE PRN DAYS BENEFITS Our competitive benefits package empowers you to live well and provides: Eligibility on da...
Jun 16, 2025
Marble Falls, TX
©2025 Phi Beta Sigma Fraternity, Inc.
Powered by TalentAlly.
Apply for this job
Director of Regulatory Affairs
Collegium Pharmaceutical
Stoughton, MA
May 12, 2025
Full-time
Your Information
First Name *
Last Name *
Email Address *
Zip Code *
Password *
Confirm Password *
Create your Profile from your Resume
By clicking the Apply button, you agree to the terms of use and privacy policy and consent to receive emails from us about job opportunities, career resources, and other relevant updates. You can unsubscribe at any time.
Continue to Apply

Collegium Pharmaceutical would like you to finish the application on their website.

Ace your interview with
AI-powered interview practice

Get comfortable talking to hiring managers, receive personalized feedback on areas for improvement, sharpen your ability to answer the most common questions, and build confidence in formulating strong responses on the spot. Click the button below to begin your three free virtual interviews!