Job Description:
• Perform general Regulatory Affairs Chemistry Manufacturing and Controls (CMC) work including dossier and document preparation for various commercial and/or development product applications.
• Support regulatory activities for the strategies aligned with Health Authority requirements from a global perspective, and supporting the on-time submission of regulatory submissions.
• Additional duties may include regulatory compliance administrative support
• Coordination with cross functional department personnel from regulatory, quality, and manufacturing sites.
• Provide support for other CMC projects and tasks as needed.
Basic Qualification:
- Bachelor's degree with 2 years experience in a Regulatory Affairs related role
- Fluency in the understanding and format of the Common Technical Document (CTD)
- Authoring experience of CTD Module 2 & Module 3 sections
- Excellent writing skills
Basic understanding of pharmaceutical manufacturing processes
Best Regards,
Anuj Mehta
973-967-3402
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Artech is an employer-of-choice for the last 25 years to over 7,500 consultants across the globe. We recruit top-notch talent for over 70 Fortune and Government clients coast-to-coast across the U.S., India, and China. We are #1 Largest Women-Owned IT Staffing Firm in the US and this may be your opportunity to join us! For more check: www.artechinfo.com