Job title: Director, Regulatory Affairs
Job type: Permanent
Emp type: Full-time
Industry: Pharmaceuticals
Expertise: Chemical / Material
Location: Allendale, NJ
Job published: 04/29/2020
Job ID: 32664
Contact name: Verónica Lituma, Alex George, Jay Bitas
Phone number: 17865746563, 561-220-3244, 561-712-0307
Contact email: veronica@aprecruiters.com, Alex@APrecruiters.com, Jay@APrecruiters.com

Job Description

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

Allendale, NJ

 

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.

 

Qualifications:

  • 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.

Required:

  • 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

 

Working Environment:

 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. 

 

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