Regulatory Chemistry, Manufacturing, Controls (CMC) – (CORK, Ireland)
In collaboration with the Global Regulatory Affairs CMC Regulatory Scientists, the CMC (Chemistry, Manufacturing, and Controls) Regulatory Associate / Sr. Associate / Manager will lead the operational and technical aspects of clinical trial and global marketing authorization submissions for the small and large molecule portfolios. The Regulatory Associate will collaborate with the GRA-CMC Scientists to produce and manage submission documents, as well as to give structure and content placement recommendations. The Regulatory Associate would work within rules to speed product registration and lifecycle maintenance, ensuring that patients receive safe and effective products.
1. Regulatory & Drug Development Expertise
- Partner with the CMC Regulatory Scientists to drive the execution of submission planning for clinical trials and global registration submissions.
- Review regulatory strategies across molecules and identify opportunities to simplify and streamline submissions for markets and/or regions.
- Interpret and implement global agency regulations, guidance and regulatory precedence into submission processes and publishing standards to ensure final document content and structure are compliant with local regulatory requirements.
- Lead CMC submission management process by providing expertise on internal processes, electronic submission regulations and guidance regarding technical content and structure requirements.
- Serve as the CMC operational lead for global clinical trial applications and registration planning and execution, including critical chain status updates.
- Understand and support the regulatory processes that enable the review and release of clinical trial materials.
- Manage CMC databases and/or information tools, prepare periodic or special request submission metrics reports to enable CMC staff to identify and address global agency trends.
2. Lead, Influence, Partner
- Lead CMC submission management processes by leveraging expertise to optimize internal processes and tools.
- Anticipate and resolve process and/or timeline issues.
- Partner with the Regulatory Scientist to plan, facilitate and document internal regulatory draft review meetings, and/or submission integration/planning sessions.
- Lead communication and transfer of registration submission commitments between GRA-CMC and Site Regulatory Affairs groups.
- Leverage internal and external forums to develop and share regulatory and drug development expertise around electronic submission structure and content.
- Communicate verbally and in writing to effectively influence the GRA function and development teams.
- Guide and influence development teams and functions regarding internal and Agency life-cycle management processes and requirements.
- Demonstrate strong problem-solving skills and ability to address and effectively communicate regulatory issues.
- Proactive in approaching higher-level colleagues in various organizations.
3. Business Expertise
- Subject matter expert (SME) responsible for the technical evaluation, implementation and documentation of CMC regulatory content, submission procedures/guidance, submission integration, and submission tracking.
- Comprehensive knowledge of evolving global agency publishing standards
- Comprehensive knowledge and skills related to the company’s systems, processes and standards.
- Demonstrate expertise in planning CMC submissions.
- Bachelor’s Degree. Scientific or health sciences discipline preferred (e.g. pharmacy, nursing, chemistry or related scientific discipline) could enable further long-term advancement opportunities
- Industry-related experience
- Combination of industry/regulatory business and/or technical knowledge and skills developed through education and experience.
- Knowledge of the drug development process
- Demonstrated ability to manage operational requirements in a regulated environment
- Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles
- Travel <5%