CMC Regulatory Affairs Manager

CMC Regulatory Affairs Manager at Katalyst CRO

• Lead preparation, review, and submission of CMC sections of regulatory filings (INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authorities.
• Provide regulatory guidance and support to cross‑functional teams throughout the product development lifecycle, including manufacturing process development, technology transfer, scale‑up, validation, and post‑approval changes.
• Interpret and communicate regulatory requirements, guidelines, and expectations related to CMC to internal stakeholders, ensuring alignment with global regulatory strategies and objectives.
• Proactively identify regulatory risks, opportunities, and challenges related to CMC activities and provide strategic recommendations to mitigate risks and optimize regulatory outcomes.
• Collaborate with internal stakeholders—Manufacturing, Quality Assurance, Quality Control, Supply Chain, and Clinical Development—to ensure regulatory compliance and alignment with business objectives.
• Establish and maintain positive relationships with regulatory agencies and industry peers, representing the company in regulatory interactions, meetings, and negotiations as needed.
• Stay abreast of emerging regulatory trends, changes, and developments related to CMC and communicate potential impacts to relevant stakeholders.

• Bachelor's, Master's, or Ph.D. degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or related scientific discipline.
• 5‑7 years of experience in regulatory affairs CMC in the pharmaceutical industry.
• Demonstrated expertise in preparing CMC sections of regulatory submissions (INDs, NDAs, BLAs, MAAs, IMPDs) and interacting with global health authorities (FDA, EMA, Health Canada, PMDA).
• Strong understanding of global regulatory requirements, guidelines, and expectations related to CMC for pharmaceutical products (ICH guidelines, FDA regulations, Eudra Lex).
• Excellent communication, collaboration, and project management skills, with the ability to effectively interact with cross‑functional teams and external stakeholders.
• Proven ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines in a fast‑paced, dynamic environment.
• Detail‑oriented mindset with a focus on quality, accuracy, and compliance.
• Experience with regulatory submissions for small molecules, biologics, or other pharmaceutical modalities is preferred.
• Regulatory Affairs Certification (RAC) is a plus.