Reporting initially to the Chief Development Officer, the VP of Regulatory Affairs will support the company mission by overseeing the following functions (responsibilities and reporting structure are expected to evolve as the organization grows including upon the hiring of a Chief Medical Officer):
Profile
- Clinical Regulatory
- CMC Regulatory
- Medical Writing
In this role, the VP of Regulatory Affairs will draw on extensive experience and strong leadership and organizational skills to develop and implement the global regulatory strategy for all company assets. S/he will also oversee related functions that are critical to our regulated development efforts. This individual must possess outstanding communication skills and interface with all parts of the company that impact regulatory issues. She/he must work productively with cross-functional product teams, external consultants, CROs, and ultimately health authorities to develop regulatory strategies that support the long-term development and registration of products. The successful candidate will take utmost care to build and nurture a strong Regulatory Affairs group within the company. This individual will mentor staff to ensure regulatory submissions meet US and global requirements (e.g., IND, CTA, health authority interactions) and company policies, and are delivered within agreed upon timelines. The ideal candidate should possess strong leadership skills, be self-motivated, and enjoy working in a dynamic, focused biotechnology company dedicated to developing transformational therapies to care for patients.
Position Responsibilities
- Provide regulatory strategic leadership for all drug development projects, including but not limited, to health authority submissions, interactions and other regulatory requirements in line with corporate objectives and timelines
- Provide de-risking development strategies and evaluating opportunities to accelerate development
- Provide leadership, and when necessary, contribute hands on support to the regulatory team in managing, planning, coordinating, and preparing all documents submitted to FDA and ex-US health authorities in support of INDs, BLAs, MAAs, DMFs, CTAs, amendments, safety reports, and annual updates
- Develop budgets and resource forecasts for the Regulatory Team
- Lead the Regulatory Team that may include external consultants or other Clinical or CMC Regulatory Affairs personnel, Regulatory Medical Writing, Quality Assurance and Pharmacovigilance and Drug Safety functions
- Grow and mentor the Regulatory Teams, with a focus on career development
- Lead all interactions with regulatory agencies including coordination of Pharmacovigilance/Drug Safety reports
- Identify appropriate vendors and manage vendor relationships supporting regulatory activities
- Interpret and communicate regulatory expectations to internal and external stakeholders (including partners, CROs, CMOs, consultants, and contractors) in order to execute program objectives in compliance with applicable regulations
- Contributes to the strategic leadership and development of policies, procedures and best practices commensurate with the requirements of a rapidly growing company
- Lead and organize internal regulatory team meetings and corresponding actions
Education/Experience/Skills
- Minimum of ten years of experience in regulatory affairs within the biopharmaceutical industry
- Prior experience and success with filing BLAs/MAAs or NDAs
- Experience with preparing regulatory documents including new INDs, safety reports, Investigator Brochures, DSURs, briefing packages and other regulatory submissions required
- Comfortable with setting strategies as well as taking a hands-on approach to all regulatory activities. Proven ability to de-risk clinical strategies in support of product development and registration
- Experience with both early and late-stage drug development
- Experience interacting directly with the FDA and other health authorities
- Knowledge of FDA regulations and EU CTA requirements required
- Strong leadership and communication skills and experience in working with multiple functional areas in a matrixed team environment required
- Possess outstanding mentorship skills and promote the career development of members of the regulatory group
- Familiar with eCTD, e-publishing systems for preparing regulatory submissions a plus
- Self-motivated with experience in a fast-paced environment
- Advanced masters level or doctoral degree in a relevant scientific discipline preferred
Alumis is an equal opportunity employer.
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