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Director Regulatory Affairs Strategy
- Posted 24 November 2022
- Salary 200000
- LocationNew Jersey
- Job type Permanent
- Reference74120
- 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
- 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 Michael.Kakoullis@biotalent.com to learn more