About the Role
The role involves guiding regulatory strategy for chemistry, manufacturing, and controls (CMC) with a focus on European Union markets, supporting product approvals and maintaining compliance across the product lifecycle.
Responsibilities
- Prepare and review regulatory submissions related to CMC for EU authorities
- Ensure compliance with current EU regulatory standards and guidelines
- Support variation submissions and post-approval changes for marketed products
- Collaborate with cross-functional teams on regulatory strategy development
- Interpret evolving EU regulations and communicate impact to stakeholders
- Manage timelines and documentation for regulatory deliverables
- Provide input on regulatory requirements during product development phases
- Assist in responding to health authority queries on CMC topics
- Maintain up-to-date knowledge of EU regulatory trends and policies
- Support audits and inspections related to regulatory documentation
- Coordinate with external partners on submission content and strategy
- Track and report on regulatory milestones and submission statuses
- Ensure consistency across regional regulatory approaches for global programs
- Review labeling and product information for regulatory accuracy
- Contribute to regulatory intelligence activities for CMC-related changes
- Support regulatory aspects of technology transfers and manufacturing changes
- Advise on regulatory pathways for new and modified products in the EU
- Participate in training on regulatory processes and updates
- Maintain regulatory databases and document management systems
- Ensure proper archiving and retrieval of regulatory records
Compensation
Competitive salary and benefits package offered
Work Arrangement
Hybrid work model with flexibility based on role and location
Team
Collaborative team environment within a global regulatory affairs organization
Why This Role Matters
This position plays a key role in advancing regulatory strategies that support timely market access in the EU, particularly for CMC-related submissions. Success in this role ensures compliance and accelerates patient access to new therapies.
What We’re Looking For
We seek a detail-oriented regulatory professional with hands-on experience in EU regulatory processes, particularly in managing CMC dossiers and lifecycle changes. The ideal candidate will combine technical knowledge with strategic insight.
Growth and Development
Opportunities for professional development include participation in global regulatory initiatives, training programs, and cross-therapeutic area projects.
Collaboration Style
This role requires regular interaction with development teams, manufacturing partners, and global regulatory colleagues to align on submission strategies and compliance requirements.
Available for qualified candidates based on business needs
