Katalyst CRO
Global Regulatory CMC Manager
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Katalyst CRO
Apply for the Global Regulatory CMC Manager role at Katalyst CRO.
Responsibilities
Participate in the development of the CMC regulatory strategy for small molecules.
Prepare and review CMC submission documents, registration dossiers, health authority briefing packages, and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
Responsible for the global regulatory evaluation of CMC change controls with supervision.
Responsible for the management of CMC activities related to developmental or commercial compounds, with supervision.
Represent Regulatory CMC on cross‑functional development/commercial teams and Regulatory Affairs teams.
Participate in global regulatory interactions with health authorities, with supervision.
Facilitate document review meetings and discussions.
Develop and maintain knowledge of the regulatory environment, regulations, and procedures.
Requirements
Bachelor’s Degree in life sciences or engineering, or other technical discipline.
3-5+ years in the pharmaceutical industry, preferably with 2+ years CMC regulatory experience.
Experience with CMC regulatory documents (IND/CTAs, NDAs, MAAs, responses, variations, and briefing documents).
Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations.
Experience in drug development processes and post‑approval requirements.
Experience in developing CMC regulatory strategy.
Experience in project management.
Solution‑oriented approach to problem solving.
Ability to plan/prioritize the work of group members and guide/develop others.
Ability to work on complex projects and within cross‑functional teams with supervision.
Excellent communication skills, both written and oral.
Employment type Full‑time
Seniority level Mid‑Senior level
Location & Salary Farmington Hills, MI – $130,000.00–$160,000.00 Novi, MI – $100,000.00–$105,000.00
Apply Now Referrals increase your chances of interviewing at Katalyst CRO by 2x.
#J-18808-Ljbffr
–
Katalyst CRO
Apply for the Global Regulatory CMC Manager role at Katalyst CRO.
Responsibilities
Participate in the development of the CMC regulatory strategy for small molecules.
Prepare and review CMC submission documents, registration dossiers, health authority briefing packages, and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
Responsible for the global regulatory evaluation of CMC change controls with supervision.
Responsible for the management of CMC activities related to developmental or commercial compounds, with supervision.
Represent Regulatory CMC on cross‑functional development/commercial teams and Regulatory Affairs teams.
Participate in global regulatory interactions with health authorities, with supervision.
Facilitate document review meetings and discussions.
Develop and maintain knowledge of the regulatory environment, regulations, and procedures.
Requirements
Bachelor’s Degree in life sciences or engineering, or other technical discipline.
3-5+ years in the pharmaceutical industry, preferably with 2+ years CMC regulatory experience.
Experience with CMC regulatory documents (IND/CTAs, NDAs, MAAs, responses, variations, and briefing documents).
Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations.
Experience in drug development processes and post‑approval requirements.
Experience in developing CMC regulatory strategy.
Experience in project management.
Solution‑oriented approach to problem solving.
Ability to plan/prioritize the work of group members and guide/develop others.
Ability to work on complex projects and within cross‑functional teams with supervision.
Excellent communication skills, both written and oral.
Employment type Full‑time
Seniority level Mid‑Senior level
Location & Salary Farmington Hills, MI – $130,000.00–$160,000.00 Novi, MI – $100,000.00–$105,000.00
Apply Now Referrals increase your chances of interviewing at Katalyst CRO by 2x.
#J-18808-Ljbffr