Biotechnology Regulatory Affairs Director

3 days ago


New York, New York, United States Volastra Therapeutics Full time
Job Title: Biotechnology Regulatory Affairs Director

We are seeking a highly experienced Biotechnology Regulatory Affairs Director to join our team at Volastra Therapeutics, Inc. The successful candidate will have a minimum of 10 years of relevant experience in the biotechnology industry, with a strong understanding of FDA regulations, EMA guidelines, and other global regulatory requirements.

The salary for this role is estimated to be around $250,000 per year, depending on experience.

Job Description:
  • Oversee standard legal matters, including intellectual property (IP), corporate governance, contracts, employment law, and litigation.
  • Efficiently handle in-house legal work, including drafting and reviewing contracts related to clinical trials and vendors.
  • Provide counsel to the C-Suite and the Board of Directors on legal risks and mitigation strategies.
Required Skills and Qualifications:
  • Minimum of 10 years of relevant legal experience, preferably both at a firm and at least one recent leadership role in house for a biotechnology or pharmaceutical company.
  • In-depth knowledge of FDA regulations, EMA guidelines, and other global regulatory requirements for clinical-stage and commercial-stage biotechnology companies.
  • Familiarity with data privacy laws impacting clinical trial data and biospecimen handling.
Benefits:
  • Total compensation package includes eligibility for an annual performance bonus and equity, along with a competitive benefits package.


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