Senior Manager CMC
Location: Dublin
Our client is a leading global pharmaceutical organization dedicated to expanding access to high-quality medicines worldwide. They are seeking an strategic and hands-on Senior Manager CMC to lead critical regulatory submissions, champion compliance, and drive complex projects from development through commercialization.
The Opportunity
In this pivotal role, you will serve as a technical anchor and strategic leader within the global regulatory matrix. You will be responsible for defining regulatory pathways, mitigating risks, and ensuring our client's diverse portfolio meets the highest standards of global compliance.
Key Responsibilities
- Strategic Leadership: Develop and execute robust, forward-thinking global CMC regulatory strategies that align scientific integrity with business objectives.
- Submission Excellence: Author, review, and deliver high-quality CMC dossiers for new registrations, post-approval variations, lifecycle renewals, and complex Health Authority responses.
- Cross-Functional Influence: Represent CMC on multidisciplinary project teams, aligning technical, R&D, and Quality operations with global regulatory benchmarks.
- Risk & Timeline Management: Lead CMC project lifecycles, proactively conducting risk assessments, managing commitments, and ensuring flawless adherence to submission timelines.
- Mentorship & Culture: Act as a technical and scientific subject matter expert, mentoring colleagues and fostering a culture of continuous improvement and regulatory excellence.
- External Engagement: Cultivate productive relationships with regulatory authorities and actively participate in industry forums to stay ahead of evolving global policies.
Core Requirements:
- Proven Expertise: Mandatory, hands-on experience authoring CMC submissions (both initial registrations and post-approval variations).
- Technical Acumen: A deep understanding of cGMPs and the product development/commercial lifecycle, enabling you to critically evaluate the scientific merit of technical data.
- Global Insight: Advanced knowledge of global regulatory expectations, submission criteria, and a proven track record of direct interactions with Health Authorities.
- Communication Mastery: Exceptional written and verbal communication skills, with the ability to translate complex scientific concepts into compelling regulatory narratives.
Why Apply?
This is an exceptional opportunity to influence a vast global portfolio, reduce regulatory burdens through smart strategy, and elevate your career within a collaborative, values-driven environment.
To Apply: Please submit your CV and a brief cover letter outlining your relevant CMC authoring experience.
