Regulatory Affairs Director

hace 4 semanas

Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completo
Job Title: Vice President, Regulatory Affairs

Company Overview: Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Job Summary: We are seeking a highly experienced Vice President, Regulatory Affairs to lead our regulatory affairs team and drive the development of innovative global regulatory strategies.

Key Responsibilities:

  • Lead the preparation and submission of high-quality sections of briefing documents, INDs, CTAs, and original marketing applications (BLAs/MAAs) in close collaboration with Nonclinical, CMC, Quality, and Clinical teams.
  • Develop and maintain a high-performing regulatory team and partner with key team members to develop strategies to advance our molecules from IND through pivotal studies and registration.
  • Drive the planning and implementation of meetings with regulatory authorities and effectively represent Tango with regulatory interactions.
  • Understand and interpret complex scientific issues for assigned projects as they relate to regulatory requirements and strategy for assigned projects.
  • Proactively identify regulatory issues and offer creative solutions and strategies, including risk mitigation.
  • Manage and implement planning, authoring, and submission of high-quality briefing documents and clinical trial applications in the US, EU, Japan, and ROW.
  • Accountable for all submissions and approvals for assigned project(s) and direct point of contact with health authorities.

Requirements:

  • Bachelor's degree in life sciences, biochemistry, chemistry, biology, or related pharmaceutical fields, including biochemical engineering; advanced degree is desirable.
  • Minimum 15 years of relevant biopharmaceutical industry experience, with at least 10 years' experience in Regulatory Affairs and deep experience in oncology; precision medicine given preference.
  • Experience interacting with regulatory health authorities and experience with submitting CTA/IND and BLA/MAA filings, ideally in an area related to oncology.
  • Familiarity with Chemistry, Manufacturing, and Control (CMC), Pharmacovigilance, and Quality, related matters, and their intersection with Regulatory Affairs.
  • Strong knowledge of drug and small molecule development regulations and guidelines, including ICH, FDA, and EMA.

What We Offer: We offer a competitive salary and benefits package, as well as opportunities for professional growth and development in a dynamic and innovative company.

How to Apply: If you are a motivated and experienced professional looking to join a leading biotechnology company, please submit your application, including your resume and a cover letter, to [insert contact information].

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