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Director - Senior Director (Regulatory Affairs)

Cambridge, MAFull-time
About the Job
A unique opportunity to become an integral part of a rapidly emerging Immuno-Oncology company. HIFIBIO Therapeutics is seeking a motivated, independent, dedicated, and flexible regulatory affairs professional who will thrive in a fast-paced dynamic company with unique potential biomarker-technology, best in class therapeutics, and a global footprint. The successful candidate will be part of and help to form an expanding regulatory affairs team, lead the determination of regulatory strategy, and drive the regulatory progress of innovative new products in Immuno-oncology, Auto-Immune, and Infectious Disease.  Regulatory programs will have the US and global focus as the programs expand and mature. The Director will collaborate with Medical, Scientific, and Manufacturing teams in the US, France, and China, as well as maintain an intimate knowledge of the latest innovations and programs to expedite drug approval.

Specific Responsibilities Include:
  • Responsible to proactively develop innovative, robust US and global regulatory strategies and ensure their efficient and effective execution for pipeline assets preparing for and in clinical development for Immuno-Oncology, Auto Immune, and/or Infectious Disease indications.
  • Understand the regulatory environment and optimal strategies for various oncology and infectious indications and support the clinical development teams as they plan and execute innovative and expedited registration programs.
  • Participate in the development of and assess the appropriateness of submission documentation to support successful INDs/NDAs/BLAs. Lead in the preparation of regulatory filings and reports.
  • Lead the strategic development of briefing materials and prepare teams for US FDA meetings.
  • Work with and participate in multi-disciplinary international matrixed teams to successfully meet project regulatory deliverables.
  • Consult with and advise senior management to develop and communicate US regulatory strategies for products.
  • Participate in the development and monitoring of the US regulatory environment and updating of standards and processes related to drug and biologics US regulations.

Requirements:
  • Bachelor's degree in a science-related field and/or other appropriate knowledge/experience. Advanced degree (M.S., Pharm. D., Ph.D., M.D.) preferred.
  • 5 to 10 years of experience or equivalent of regulatory drug development in immune-oncology and/or infectious disease including preparation and submission of INDs.
  • Specific knowledge and experience with biomarker-driven regulatory development and approval pathway is strongly desired.
  • Experience working in regulatory affairs in a biotech or pharmaceutical company and/or prior experience working at the US or European health authority.
  • Proven leadership and program management experience.
  • Ability to think strategically, and critically evaluate risks to regulatory activities.
  • Ability to work strategically within a complex, business-critical and high profile development program.
  • Successful contribution to a major regulatory approval at a global or regional level.
  • A scientific and clinical understanding of the regulatory sciences.
  • Must demonstrate competencies of: strategic thinking, strategic influencing, innovation, initiative, leadership, and excellent oral and written communication skills.

Knowledge, Skills & Other Experience:
  • Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.
  • Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving US regulatory policy and guidance.
  • Direct interaction/negotiation with regulatory authorities (e.g. FDA).
  • Team player, ability to work well within cross-functional teams, and in a multicultural/multinational environment.
  • Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities.
  • Excellent oral (including presentation) and written communication skills (including medical writing).
  • Strong organizational, computer dbase, time and project management skills, with proven ability to plan and track deliverables/timelines.
  • Ability to work well in an international matrix environment.
  • Ability to prioritize and adapt to the changing needs of the business.
  • Domestic and international travel may be necessary.
About HiFiBiO Therapeutics

HiFiBiO Therapeutics is an emerging multinational company mobilizing the human immune system to combat disease and transform patient care. We integrate deep-rooted biological expertise, apply advanced single-cell profiling technologies and leverage open-innovation strategies to accelerate the development of a repertoire of innovative antibody drugs to treat cancer and autoimmune disorders.