Job Description
Join the Vanguard of Medical Innovation.
Catalyst Therapeutics is at the forefront of biopharmaceutical breakthroughs. We are seeking a strategic and detail-oriented Senior Regulatory Affairs Manager to lead the regulatory strategy for our next-generation therapeutics. If you are passionate about bringing life-saving treatments to market and thrive in a high-performance, collaborative environment, we want to meet you.
Why Catalyst Therapeutics?
• Competitive compensation and equity package.
• Comprehensive health, dental, and vision coverage.
• Professional development and continuing education support.
• Flexible work arrangements and a culture of inclusion.
Responsibilities
- Lead Regulatory Strategy: Direct the regulatory strategy and planning for IND, NDA, and BLA submissions in the US and international markets.
- Submission Management: Own the regulatory dossier lifecycle, ensuring all submissions are complete, accurate, and submitted on time to the FDA and EMA.
- Agency Liaison: Act as the primary point of contact for interactions with regulatory authorities, including pre-submission meetings and responses to queries.
- Cross-Functional Leadership: Collaborate with R&D, Clinical Operations, and Quality Assurance teams to ensure regulatory requirements are integrated into development plans.
- Change Management: Manage regulatory changes, including amendments and supplements, ensuring continuous compliance with evolving regulations.
- Compliance Oversight: Monitor global regulatory trends and ensure the company maintains compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
Qualifications
- Education: Bachelor’s degree in Biology, Chemistry, Pharmacy, or related scientific field; Master’s degree (MS) or PharmD is preferred.
- Experience: Minimum of 5-7 years of progressive experience in Regulatory Affairs within the biotechnology or pharmaceutical industry.
- Technical Knowledge: Deep understanding of FDA 21 CFR Part 11, ICH guidelines, and international regulatory frameworks (FDA, EMA, PMDA).
- Leadership: Proven track record of leading cross-functional teams and managing complex regulatory projects.
- Communication: Exceptional written and verbal communication skills, with the ability to translate complex regulatory concepts for diverse stakeholders.
- Software Proficiency: Advanced proficiency in regulatory submission software (e.g., Veeva Vault, RegWorks) and MS Office Suite.