Our client is seeking an experienced Regulatory Affairs professional to join their team based in North-Central New Jersey. The ideal candidate will have a strong technical background in Chemistry, Manufacturing, and Controls (CMC) regulatory requirements, with proven expertise in technical writing for dossier submissions.
The Regulatory Affairs Manager will be responsible for ensuring compliance with all regulatory standards and guidelines, leading the preparation and submission of regulatory documents including CMC modules, and overseeing the development of generics including Risk Evaluation and Mitigation Strategies (REMS) programs.
Key Responsibilities:
- Develop and implement regulatory strategies for CMC submissions, ensuring alignment with industry standards and regulatory requirements.
- Prepare, review, and submit regulatory dossiers, including INDs, NDAs, and ANDAs, with a focus on technical accuracy and clarity.
- Manage and support the Risk Evaluation and Mitigation Strategies (REMS) programs, collaborating with cross-functional teams to ensure compliance and effectiveness.
- Maintain current knowledge of regulatory changes and industry trends to provide guidance and support to internal stakeholders.
- Serve as a liaison with regulatory agencies, responding to inquiries and facilitating communication regarding submissions and compliance issues.
Key Requirements:
- Bachelor’s degree or higher in a relevant scientific discipline.
- 3-8 years of experience within the pharmaceutical industry, with a strong focus on CMC regulatory affairs.
- Proven experience in technical writing for regulatory submissions (CMC modules), demonstrating attention to detail and clarity.
- Excellent communication and interpersonal skills, with the ability to work collaboratively in a team-oriented environment.
Preferred Qualifications:
- Prior experience with generic pharmaceuticals.
- Experience managing Risk Evaluation and Mitigation Strategies (REMS) products/programs.
