What are the responsibilities and job description for the Associate Director, Regulatory Affairs Strategy - Safety & Toxicology position at Proclinical Staffing?
Associate Director, Regulatory Affairs Strategy – Safety & Toxicology – Permanent – New Jersey
Proclinical is seeking an Associate Director, Regulatory Affairs Strategy – Safety & Toxicology for a growing medical equipment and supplies manufacturing company based in New Jersey.
Primary Responsibilities:
In this role, you will develop and execute product safety strategies that drive business innovation while ensuring regulatory compliance. This role will provide leadership and guidance for regulatory submissions, health authority interactions, new product development, and existing product maintenance as well as overseeing raw material and formula clearance for product safety and compliance. The ideal candidate will combine strong regulatory knowledge with hands-on experience to ensure product safety over the full life cycle of a diverse portfolio of healthcare and consumer regulated products including but not limited to drugs, devices, cosmetics, surface sanitizers and disinfects.
The position has a hybrid work schedule (4 days per week in-office, 1 day remote) based in New Jersey.
Skills & Requirements:
- Bachelor’s degree in life sciences, pharmacy, or related field required; advanced degree (PharmD, PhD, MS) and/or CCCTO or DABT certifications a plus
- Solid knowledge of FDA safety regulations; experience with ex-US authorities (Health Canada) desirable
- Demonstrated ability to contribute to safety strategies and regulatory submissions across multiple phases of development
- 8-10 years of safety experience in pharmaceuticals, biotech, medical devices, or pesticides including submission experience in IND/NDA, 510(k), FIFRA §3 or equivalent
The Associate Director, Regulatory Affairs Strategy – Safety & Toxicology will:
- Lead Product Safety and Toxicology team in developing and executing safety strategies for new product development and maintenance of existing products to ensure successful commercialization across product life cycle
- Develop and execute non-clinical safety strategies to generate pre-clinical data for new product development marketing authorization applications
- Investigational/New Drug Applications (IND/NDA)
- Medical Devices Pre-Market Notifications (510(k))
- Pesticides – FIFRA §3
- Develop and execute non-clinical safety strategies for qualifying impurities and new inactive ingredients
- Assess non-clinical safety data and advise project teams on potential in-vitro and in-vivo clinical and non-clinical safety study requirements
- Design, coordinate and monitor in-vitro and in-vivo clinical and non-clinical safety studies
- Ensure studies comply with Good Laboratory Practice (GLP) standards and FDA and HC recognized regulatory guidelines
- Author and review non-clinical sections of regulatory submission documents (IND/NDA/510(k)/FIFRA §3)
- Prepare, oversee, and deliver raw material and formulation toxicological risk assessments, safety clearances, and Consumer Products Safety Reviews (CPSR)
- Prepare, oversee, and deliver Safety Data Sheets (SDS) for drugs, devices, disinfectants, cosmetics and cleaning products
If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at ( 1) 646-779-7961 or p.huynh@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.