Category: Scientific & Clinical
Title: Clinical RA Manager
Location: Princeton NJ
Start Date: Immediate Need
Salary: Competitive salary offered with full benefit package
- Minimum Bachelor’s degree in Pharmacy, Biology, Chemistry or related healthcare functional area; advanced degree preferred.
- Strong scientific background with at least five (5) years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries
- Extensive experience in preparation, submission and approval of INDs/CTAs and marketing applications (NDA/BLA/MAA).
- Proven ability to successfully manage major submissions and critical projects timelines.
- Experience in addressing clinical-related regulatory queries from global health authorities
- Experience with leadership role in HA negotiations.
- Excellent medical writing, communication and management skills
- Professional Training Regulatory Affairs Certification (RAC) preferred
- Prefer experience in either therapeutic area- CNS and/or oncology
1. Regulatory project management
- Create and maintain regulatory timelines and track deliverables
- Interface with functional areas to identify and obtain information required for regulatory submission
2. Regulatory document preparation and submission
- Develop and/or review regulatory documents to ensure that all submissions are of high quality
- Prepare/coordinate/file/manage the nonclinical, clinical and CMC content of IND/CTAs, annual reports, and information amendments in multiple countries
- Support the preparation and filing of the regulatory applications (IND/CTA, NDA/BLA/MAA)
3. Regulatory strategy
- Provide strategic input and regulatory advice to the project teams on development programs
- Proactively identify project issues and implement appropriate regulatory strategies to mitigate risks
4. Interaction with Health Authorities
- Interface with global regulatory authorities and consultants as needed
- Lead/coordinate the preparation of responses to questions from Regulatory Authorities
- Support the preparation and conduct of Agency meetings as necessary
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.