Katalyst CRO · 3 months ago
Sr. Manager CMC Regulatory
Atlanta, GA
Contract
Onsite
Senior Level
7+ years expKatalyst CRO is seeking a Sr. Manager CMC Regulatory to develop and implement global CMC regulatory strategies. This role involves coordinating CMC regulatory activities to support clinical development and marketing approval of pipeline products, ensuring compliance with regulatory requirements across regions.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
This position is responsible for developing and implementing global CMC regulatory strategies
The role involves coordinating CMC regulatory activities to support the clinical development and eventual marketing approval of RevMed's pipeline compounds / products
Collaborate, and manage the CMC regulatory activities for global clinical trials, ensuring compliance with regulatory requirements across regions (FDA, EMA, APAC, etc.)
Collaborate with internal stakeholders to support the preparation of CMC / quality sections for regulatory submissions including initial submission of IND, IMPD/CTA, NDA, MAA and amendments to Health Authorities (HAs), and preparation of responses to queries from Has
Assess changes to clinical trial materials or processes and prepare the necessary documents for regulatory amendments
Identify and mitigate regulatory risks, manage CMC timelines and milestones, and ensure the timely submission of high-quality CMC dossiers to support clinical trials
Provide updates to senior management on regulatory activities and submission progress
Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stakeholders
Represent department in cross-functional project teams
Participate in the regulatory process initiatives and improvement activities
Qualification
Required
The ideal candidate should have a strong understanding of regulatory requirements and be able to guide CMC teams throughout the drug development process
BA/BS degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field
7+ years of pharmaceutical / biotech drug development experience in CMC development of NCEs / small molecules with 3+ years of CMC regulatory experience
Experience in leading CMC related global submissions (IND, IMPD/CTA, NDA, MAA, etc.)
Solid knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues
Demonstrated experience in effective collaboration with internal and external stakeholders
Ability to prioritize and manage multiple projects simultaneously in a dynamic company environment
Effective written and verbal communication skills and good interpersonal skills
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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