Director Regulatory Affairs Strategy

Posted 24 November 2022
Salary 200000
LocationNew Jersey
Job type Permanent
Contact NameMichael Kakoullis

Job description

BioTalent has partnered with an existing multinational biopharmaceutical company in New Jersey who are looking to expand their regulatory affairs team through a senior hire.
This role will offer you

  • A chance to work in both new product and existing product development across global regions
  • A clear progression pathway into further roles both locally and internationally
  • To work for a global leading brand leading

You will be responsible for:
  • Leading the day-to-day operations of a small local global team across select project pipelines
  • Working toward submissions of new products across the US and EU regions
  • Provide guidance to local regulatory stakeholders
  • Act as a key stakeholder within the regulatory framework
You will need to bring:
  • Strong NDA/BLA and MAA experience in both new product registration and maintenance of existing
  • Direct interaction with regulatory authorities particularly with the FDA and EMA
  • Worked with either small molecule or biologics

If this role is something of interest please reach out on 857-990-4669 or at to learn more