What are the responsibilities and job description for the CMC Regulatory Affairs Manager position at Katalyst CRO?
Responsibilities
- Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authorities, ensuring accuracy, completeness, and compliance with applicable regulations and guidelines.
- 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, including 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 (e.g., INDs, NDAs, BLAs, MAAs, IMPDs) and interacting with global health authorities (e.g., FDA, EMA, Health Canada, PMDA).
- Strong understanding of global regulatory requirements, guidelines, and expectations related to CMC for pharmaceutical products (e.g., ICH guidelines, FDA regulations, EudraLex).
- 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.