Regulatory Affairs Director Jobs Everywhere
(Found 284 Jobs)

Director of Regulatory Affairs
Collegium Pharmaceutical
Job responsibilities:Develop regulatory strategies integrated with cross functional project teams and external stakeholders to facilitate timely subscriptions and approvals for post market regulatory
May 12, 2025
Stoughton, MA

Director - Regulatory Affairs
Avangrid
The base salary range for this position is dependent upon experience and location, ranging from: $153,000 - $191,000.Job Summary: The Director Regulatory Affairs is the primary regulatory relationship...
May 24, 2025
Clifton Park, NY

Director - Regulatory Affairs
Avangrid
The base salary range for this position is dependent upon experience and location, ranging from: $153,000 - $191,000.Job Summary: The Director Regulatory Affairs is the primary regulatory relationship...
May 24, 2025
Albany, NY

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 8, 2025
Harrisburg, PA

Director, Global Regulatory Affairs Labeling
Ultragenyx
Why Join Us?
Be a hero for our rare disease patients
At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the rig...
Jun 7, 2025
Novato, CA
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