Vice President Regulatory Affairs

Job Description

Crystalys Therapeutics is a dynamic, startup, San Diego biotech organization focused on advancing innovative therapies in rheumatology through Phase 2 and Phase 3 clinical trials. They have completed their series A financing with a runway into the middle of 2028.

Ideally, this is a Hybrid role (located in San Diego, CA).  Crystalys Therapeutics is searching for a highly motivated and skilled Regulatory professional.

JOB SUMMARY

Reporting to our Chief Medical Officer, the Vice President, Regulatory Affairs will be responsible for leading the development and implementation of a consolidated regulatory strategy to secure and maintain market access for the assigned product through all development phases. The Vice President is also responsible for establishing and maintaining effective relationships with regulatory agencies, especially the FDA. This role will participate as a core project team member and will manage regulatory personnel and interact with Core Team members, agencies / health authorities to obtain and maintain product approvals with a focus on quality regulatory submissions. Facilitates policy and development of standard interpretation of global regulations. Cultivate an atmosphere of transparency and open communication within each cross-functional team and support corporate goals.

Essential Duties and Responsibilities

• Develop and implement global regulatory strategy for assigned projects, along with Regulatory Affairs representatives and Regulatory CMC.
• Partner with other company leaders to execute the lead product development plan according to the Target Product Profile, focusing on target product characteristics, developmental risk assessment and regulatory risk management, and target product claims.
• Trains, develops, and manages an effective regulatory team, both via direct and indirect reporting structure. Be responsible for their professional development and support their outputs as defined by departmental goals and deliverables.
• Liaises and negotiates with US / EU regulatory authorities as needed for all aspects of drug development including resolution of key regulatory issues. Serve as the primary interface for FDA on assigned projects.
• Communicate project regulatory strategies and plans to management, cross- functional teams and any partners / collaborators to establish alignment.
• Review submissions, which may include INDs / CTA, milestone briefing packages, Orphan Drug Applications, and Marketing Applications, and other major regulatory submissions for content and conformance with regulatory requirements.
• Prepare company team for FDA and other health agency meetings, as required.
• Develop and manage regulatory work plans for major submissions, health authority interactions, and other relevant activities, covering strategy, documentation, delegation and functional area collaboration, and budget.
• Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Teams and Study Teams.
• Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances.
• Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
• Participates in Business Development efforts, as assigned.
• Manage critical issues, taking leadership for the regulatory contribution.

JOB QUALIFICATIONS

Education, Certifications, Experience

Knowledge, Skills and Abilities

SPECIAL WORKING CONDITIONS

Domestic and / or International travel may be necessary (20%)

We offer :

Crystalys prides itself on being an inclusive employer and provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military or any other classification protected by law.