Job Purpose/Summary:
We seek an experienced Regulatory professional to manage regulatory activities associated with pipeline and late phase clinical development, working in partnership with the development R&D team and CMOs. This position reports into the SVP Regulatory Affairs and Quality Assurance. The candidate must be able to interpret biologic/ATMP regulations as they apply to given phases of drug development including preclinical, clinical and commercial. This is an exciting team-building, hands-on leadership role within the Sonoma Biotherapeutics team. The position will be based in the US in the SSF headquarters. Remote US candidates are also considered.
Roles and Responsibilities:
- Proactively participate in design of global regulatory strategies for the development of gene therapy products for rare diseases
- Oversee and manage preparation and submissions (including but not limited to protocol amendments, Initial INDs, Pre-IND/EOP meetings, CTAs, BLA/MAA, Fast Track/Breakthrough and PIPs) of high-quality regulatory according to set timelines; this will require, strong regulatory knowledge and experience, cross-functional interactions, excellent project management and writing skills, and a good understanding of the underlying science.
- Interface with Regulatory counterparts (Reg CMC and Reg Ops) and collaborate with the nonclinical, clinical and CMC teams to ensure seamless strategy and integration of components in all initiatives and submissions
- Participate in interactions and negotiations with regulatory agencies to clarify and solidify strategy and resolve issues
- Lead preparation of agency meetings and actively participate in scheduled meetings
- Drive adherence to regulatory requirements and guidelines
- Perform regulatory intelligence activities - monitor regulation changes and competitor trends/strategy
- Provide regulatory input regarding budget
- This position requires 15-20% travel
Qualifications and Education Requirements:
- BA/BS degree in life sciences - preferably in biotechnology, chemistry and/or biology. MS/PhD preferred but not required
- At least 8-10 years of regulatory pharmaceutical product development experience - preferably in biotechnology, ideally in cell & gene therapy
- Well-versed in regulatory strategy and regulatory science writing
- Knowledgeable in ICH, FDA, EMA and WHO regulations/guidelines
- Ability to work independently and thrive in a fast-paced environment
- Strong attention to detail and well organized and able to multi-task
- Outstanding communication and time management skills
- Passionate about patient-focused drug development toward finding cures for patients in need
