Associate Director Regulatory Affairs

Apply for this job

Upload your CV/resume or any other relevant file. Max. file size: 1 MB.
I have read and agree with Privacy Policy


You can apply to this job and others using your online resume. Click the link below to submit your online resume and email your application to this employer.

Share job
Posted February 4, 2025
Location New Jersey, USA
Job TypeFull Time, Permanent
Market CDMO
VerticalAnalytical, Project Management, Regulatory Guidelines

Serena Vigano

Mantell Associates

Mantell Associates is currently partnered with a leading CDMO working within clincial manufacturing in their search for an Associate Director of Regulatory to join their growing team.

Associate Director of Regulatory Affairs – Responsibilities:
 

  • Develop and oversee regulatory strategies, ensuring compliance with local regulations and guidelines 
  • Lead regulatory submissions for clinical trials and product approvals, including interactions with regulatory agencies, consultants, and partners
  • Build and maintain relationships with regulatory authorities, key opinion leaders, and industry associations
  • Provide strategic advice to cross-functional teams on regulatory requirements and timelines for product development and commercialisation
  • Ensure the company’s quality system is in compliance with regulatory requirements, and lead regulatory inspections
  • Stay up-to-date with regulatory developments and trends in the biotech industry and provide guidance to the company on emerging regulatory issues
  • Oversee and develop the regulatory affairs team, including recruitment, training, and performance management

 

Associate Director of Regulatory Affairs – Requirements:

 

  • Advanced degree in a scientific or related field, with strong regulatory affairs experience in the biotech or pharmaceutical industry
  • Extensive knowledge of regulatory requirements for drug development and product approvals
  • Proven track record in successful interactions with regulatory authorities and successful regulatory submissions
  • Strong leadership and people management skills, with experience leading and developing regulatory affairs teams
  • Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders
  • Strong analytical and problem-solving skills, with the ability to manage multiple priorities in a fast-paced environment

 

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.

Tagged as: Analytical, Project Management, Regulatory Guidelines

Apply for this job

Upload your CV/resume or any other relevant file. Max. file size: 1 MB.
I have read and agree with Privacy Policy


You can apply to this job and others using your online resume. Click the link below to submit your online resume and email your application to this employer.