Title: Regulatory Strategist
Location: New Jersey
Duration: 12 Months (Contract-to-Hire)
Rate: To be discussed…
The position is to provide regulatory affairs strategic support for the company's drug development programs. The individual will work with the lead regulatory strategist and extended development team for executing the overall regulatory strategy, which includes handling all regulatory submissions, document preparation, and team meeting minutes.
- Support regulatory strategist for assigned investigational and approved small molecule and/or biologics.
- Work with regulatory team to insure supported development programs are compliant with ICH regulatory requirements and all local country regulatory requirements.
- Strong project management skills and strong interpersonal skills to handle complex distributed programs.
- Experience in authoring clear and concise regulatory documents, including cover letters, regulatory forms, dossier components, and other regulatory documents.
- Work closely with CMC lead and overall development team to insure overall regulatory strategy and regulatory CMC strategy are aligned.
- Bachelor's degree in Chemistry, Biochemistry, Pharmacy, Biomedical Engineering, or Chemical Engineering.
- 3 years in Regulatory Affairs
- 5 years within the pharmaceutical industry
- Master's degree or higher in above disciplines
- 5 years within Regulatory Affairs
- 10 years within the pharmaceutical industry
- Understanding of ICH and US CFR requirements and regulations.
- Regulatory document submissions authoring experience (INDs, IMPDs, NDAs, BLAs, briefing books)
- Supported regulatory agency interactions, either through attendance, leadership or preparation
- Strong communications skills
Sthree US is acting as an Employment Business in relation to this vacancy.