Senior Director, CMC Regulatory
We are seeking an exceptionally motivated individual to provide leadership and support to global regulatory activities and to the CMC teams at Alumis 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 Senior Vice President, Regulatory and Quality.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Responsible for leading regulatory CMC activities for assigned projects in line with ICH requirements, regional requirements, and company policies and procedures
- Contributes to the development and implementation of global CMC regulatory strategies in conjunction with global clinical regulatory strategies, identifies risks and proposes risk mitigation strategies, and influences project teams and subteams
- 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.
- Responsible for preparing and reviewing technically complex regulatory CMC submissions; Establish and meet aggressive timelines for regulatory submissions related to INDs/CTAs, global NDAs / MAAs, ensuring that sound scientific justification is employed.
- Interact with Regulatory Affairs personnel within external service providers and development partner companies.
- Maintain knowledge of current regulatory requirements and communicates changes in regulatory information to cross-functional teams and senior management.
EDUCATION/EXPERIENCE/SKILLS:
- 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; small molecule development experience desirable.
Knowledge/Skills/Abilities:
- Direct experience with pharmaceutical regulatory submissions and product approvals, managing major regulatory filing(s) such as IND/CTA or NDA/BLA/MAA.
- Experienced in building highly functioning teams, developing staff and defining, crafting and overseeing the execution of innovative regulatory strategies
- Extensive knowledge of FDA regulations and practices and ICH guidance as well as strong knowledge of global health authority regulations and practices.
- Demonstrated leadership and success in management of regulatory activities with a proven track record of effective collaboration with Global regulatory agencies, including the FDA.
- Excellent verbal and written communication skills.
- 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; prior management experience a plus.
- Previous experience in successfully leading assigned activities within cross-functional teams.
- Some travel required. Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
Alumis Values:
- We Elevate
- We Challenge
- We Nurture
The salary range for this position is $255,000 USD to $280,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.