What are the responsibilities and job description for the Regulatory Affairs CMC Senior Manager position at Katalyst CRO?
Responsibilities
- The Regulatory Affairs CMC Senior Manager at is responsible for providing strategic direction, tactical support, and technical expertise for CMC regulatory activities and related regulatory initiatives.
- Responsible for guiding and overseeing the preparation of complex regulatory CMC submissions for investigational and commercial products with solid scientific foundations, in compliance with ICH and regional requirements, and in alignment with company policies and procedures.
- Works collaboratively in cross functional matrix teams to develop a CMC submission plan in accordance with business objectives.
- Actively collaborates with internal teams (including Technical Development and Manufacturing, Supply Chain and Quality) to identify and rank risks, proposes risk mitigation plans, develops, and executes robust CMC regulatory strategies.
- Provides advice and drives decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
- Provides regulatory impact assessments for changes managed in the quality systems and participates in technical risk assessment exercises.
- Collaborates with colleagues across the global RA CMC organization, Gilead regulatory affairs, and affiliates on internal meetings and Health Authority interactions.
- Proves ability to remain current on CMC regulatory intelligence including guidelines and regulatory trends.
- Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments).
- BA in relevant scientific discipline and 8 years of experience OR
- MS in relevant scientific discipline and 6 years of experience OR
- PhD/PharmD in relevant scientific discipline and 2 years of experience OR MD
- Has 5 years of relevant experience in Regulatory Affairs CMC or other relevant industry experience with advanced degree. Experience in scientific/technical field is preferred.
- A bachelor's degree in a relevant scientific discipline. An advanced degree is preferred.
- A proven track record of developing global CMC regulatory submissions strategies in all phases of drug development, including life cycle management.
- Collaborative, proactive, and highly organized approach to work.
- Demonstrated track record with strategic planning, problem solving, and working within a global matrix team environment, successfully managing CMC regulatory activities and initiatives.
- Deep understanding of global regulatory requirements and guidelines.
- Excellent communication and interpersonal skills.
