Associate Director, Regulatory Affairs
South San Francisco, CA
Regulatory /
Full-time /
Hybrid
The Associate Director, Regulatory Affairs is part of the Alector Regulatory Affairs team based in the San Francisco Bay Area. This individual will support regulatory activities critical to the company’s product development objectives as regional and regulatory support for one or more programs and leads cross-functional initiatives. This position requires you to be onsite for a minimum of 2 days a week.
Specific responsibilities include:
- Responsible for developing regulatory strategies and identification of risks for assigned projects in coordination with the Director of Regulatory Affairs through all phases of development in line with objectives, timelines, and budgets.
- Represent Regulatory Affairs on project teams and closely collaborate with multidisciplinary teams to identify submission requirements and define timelines to ensure timely delivery of high-quality, compliant, accurate and complete regulatory submissions. Liaises within Regulatory sub functions to coordinate work in support of project team goals.
- Participate in collaboration partner meetings and activities.
- Ensure CROs and other vendors are implementing regulatory strategy for global submissions.
- Present regulatory strategies for Senior Management endorsement and at governance meetings
- Lead internal meetings and ensure development of robust regulatory strategies for the program, including critical input on clinical development plans, Target Product Profile (TPP), commercial landscape reviews, regulatory risk assessments, etc.
- Demonstrate leadership within the regulatory affairs department and cross-functionally by driving the development, finalization, implementation, and maintenance of initiatives, processes, and procedures.
- Proactively communication with the Regulatory, PV, and Quality Leadership team on program risks, strategies, and updates.
- Navigate team and CRO structure.
- Evaluate and identify gaps in internal processes/SOPs and develop plans to address in conjunction with line manager.
- Ensure compliance with corporate policies and procedures and health authority laws and regulations.
- Review submissions to regulatory authorities to support successful clinical trial applications, INDs and marketing applications.
Basic Qualifications
- Minimum of 5 years regulatory experience required.
- BA/BS degree required, advance degree in the life sciences preferred.
Knowledge, Skills, and Other Experience
- Possess and maintain an advanced level of understanding and awareness of existing and emerging regulations and guidelines, as well as competitor landscape, and be able to interpret, apply and effectively communicate those that are applicable to the company’s projects to both senior management and peers.
- Ability to work well and foster teamwork within cross-functional teams and external collaborations.
- Ability to manage multiple clinical programs and coordinate and prioritize activities independently.
- Enterprise approach/thinker.
- Think strategically and be proactive/self-driven to complete tasks as directed.
- Ability to influence decision-making without authority.
- Proven regulatory leadership on projects and in interactions with regulatory agencies.
- Solid knowledge and understanding of sophisticated, evolving scientific and regulatory topics and apply to internal activities.
- Excellent verbal communication and writing skills.
- Strong leadership and interpersonal skills with a reputation for collaboration with cross-functional colleagues.
- Experience with cloud-based document management programs (e.g., Veeva) and/or document management systems and co-authoring tools.
- Experience with planning, lifecycle and submission of initial INDs and CTAs.
- Experience with planning and submission of BLAs is preferred.
- Willing to travel on occasion.
- Outstanding ethics and integrity.
$200,000 - $228,000 a year
Base salary ranges will be determined by the candidate's level, qualifications, skill set, and experience.
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