Regulatory Affairs Director

3 days ago

South San Francisco, California, United States BioSpace, Inc. Full time

Regulatory Affairs Director

We are seeking a highly motivated individual to provide leadership and support to global regulatory activities to achieve our strategic vision in obtaining worldwide approvals to market our products.

The individual will represent Regulatory Affairs and work closely with cross-functional teams and development partners while managing relationships and interactions with external strategic and technical regulatory service providers in accordance with health authority and ICH requirements.

In addition to being a key member of our project teams, she/he will provide organizational support as the company and its product development pipeline grow.

This role will report to the Executive Director and Head of Regulatory Strategy.

Key Responsibilities:

  • Develop and implement regulatory strategies to facilitate the progress for assigned programs in all phases of development.
  • Serve as the Regulatory Affairs representative on assigned project teams and assure the progress of projects by providing direction, solutions and feedback to the teams in support of regulatory approvals.
  • Lead interactions with regulatory agencies for assigned programs.
  • Establish and meet timelines for regulatory submissions related to INDs/CTAs, including nonclinical, clinical, and CMC activities, while planning for global NDAs / MAAs.
  • Interact with Regulatory Affairs personnel within external service providers.
  • Maintain awareness of current regulatory requirements and communicate requirements in support of regulatory approvals.

Requirements:

  • Bachelors or advanced degree in a scientific discipline, with a minimum of 10 years of experience working in drug development in the biopharmaceutical industry and at least 8 years of experience in Regulatory Affairs.
  • Direct experience with pharmaceutical regulatory submissions and product approvals, contributing to major regulatory filing(s) such as IND/CTA or NDA/BLA/MAA.
  • Experience leading regulatory agency interactions.
  • Demonstrated leadership and success in management of regulatory activities and previous experience in successfully leading assigned activities within cross-functional teams.
  • Experience in providing strategic advice on integrated regulatory development plans and life cycle management.
  • Collaborative, analytical and interpretative skills that enable review and compilation of reports and other documents used in regulatory planning and submissions.
  • Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others; Some travel required.

What We Offer:

  • Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.
  • Free access to Genentech Bus & Ferry Share program.
  • ~$100 monthly cell phone stipend.
  • Free onsite gym and a kitchen stocked with yummy snacks and drinks.

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