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Regulatory Affairs Lead in Small Molecule Operations
1 month ago
We are seeking a seasoned Principal Regulatory Affairs Consultant to join our team at Lifelancer. As a key member of our Life Sciences talent-hiring platform, you will be responsible for providing expert regulatory affairs support to clients across the pharmaceutical industry.
About the RoleThis is a unique opportunity to leverage your knowledge and expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule processes. You will work closely with clients to develop and implement submission strategies and plans for post-approval CMC activities, ensuring compliance with regulatory requirements.
Key Responsibilities:- Lead projects from planning to execution, ensuring successful project outcomes and client satisfaction.
- Maintain accurate project reporting and communicate effectively with clients to meet their expectations.
- Develop and implement submission strategies and plans for post-approval CMC activities, including variations, renewals, market expansions, and annual reports.
- Assess change controls and provide regulatory assessments of quality changes in production and quality control.
- Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.
- Coordinate submission preparation with various departments, including manufacturing, supply chain, quality control, and quality assurance.
- Write and review submission content to ensure alignment with regulatory requirements.
- Collaborate within a team environment to deliver project requirements, prioritize workloads, and achieve project scope and objectives.
- Deliver engaging presentations at seminars and industry group meetings, author articles for industry publications, and demonstrate expertise and showcase capabilities.
- Identify, escalate, and mitigate risks associated with regulatory procedures and activities.
- Mentor and coach more junior members of the team.
- University-level education in Life Sciences or equivalent by experience.
- Extensive experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.
- Strong understanding of CMC and post-approval regulatory requirements.
- Experience in writing CMC sections of regulatory documents such as registration files or variations.
- Knowledge of small molecule processes.
- Proficient account planning and support abilities.
- Networking skills to expand professional connections.
- Team spirit, flexibility, accountability, and organizational skills.
- Strong project leadership and management knowledge.
- Strong business acumen for analysis and decision-making.
- Self-confidence and control in professional engagements.
- Fluent in English (written and spoken).
