AP Recruiters & Associates
We go the extra mile to make both our clients and candidates happy. The Right talent at the Right time.
We are a State of Florida certified Minority and Veteran Owned Business serving clients nationwide since 2007.
Director, Regulatory Affairs
COVID-19 Related Update:
Interviews will be conducted via video calls:
Candidates will conduct interviews online.
Potential for new employees starting remotely:
If hired, employees will initially receive training remotely and may be able to temporarily start working remotely from home for select roles, until the COVID-19 situation is resolved.
- BA/BS in the Life Sciences is required. MS or PhD in chemistry or biology and/or Regulatory Affairs is strongly preferred.
- Minimum 7-10 years in Regulatory Affairs in an FDA Regulated Industry is required
- Thorough knowledge of ICH Guidelines and FDA cGMPs and Guidelines is required. Knowledge of European and Japanese Health Authority requirements is strongly preferred
- CMC Regulatory experience in cell therapies is required
- Regulatory Affairs Certification preferred
- Ability to work independently with minimal supervision is required
- Proven interpersonal skills with face to face and remote teams
- Minimum Required Training
- Incumbent will be expected to complete all assigned GxP and Compliance related training in accordance with assigned due dates.
- BS degree in scientific field
- 5+ years of high-level Reg Affairs experience
- Experience creating/revising SOP
- Must be willing to be an individual contributor and not "a manager"
- Must come from GMP company
This is an office-based position in the Allendale, NJ location. Phone conferences outside of normal working hours is occasionally required in order to interact with global counterparts. Travel less than 25% is required.