About the Role
Provides strategic regulatory input on CMC aspects to support product registration and lifecycle management in alignment with international standards.
Responsibilities
- Advise on regulatory strategies for chemistry, manufacturing, and controls documentation
- Support the development of regulatory submissions for global health authorities
- Ensure compliance with evolving regulatory requirements across regions
- Collaborate with cross-functional teams to align development plans with regulatory expectations
- Prepare and review CMC sections of regulatory dossiers
- Interpret regulatory guidelines and translate them into actionable development steps
- Engage with regulatory agencies as part of submission processes
- Maintain up-to-date knowledge of global regulatory landscapes
- Guide internal teams on regulatory implications of manufacturing changes
- Support inspection readiness for regulatory audits
- Contribute to regulatory intelligence activities
- Assist in the development of regulatory project timelines
- Evaluate regulatory risks associated with product development paths
- Provide input on regulatory impact of new technologies or processes
- Support due diligence for regulatory aspects in business development
- Ensure consistency of regulatory strategy across product lifecycle stages
- Participate in regulatory meetings and discussions with health authorities
- Develop regulatory position papers and briefing documents
- Monitor regulatory trends affecting CMC requirements
- Advocate for regulatory best practices within project teams
- Support training initiatives on regulatory topics
- Coordinate with external partners on regulatory deliverables
- Review manufacturing and quality documentation for regulatory compliance
- Contribute to responses for regulatory queries
- Maintain regulatory databases and tracking systems
Work Arrangement
Hybrid
Team
Collaborative team environment focused on regulatory compliance and product development support.
About the Role
This position plays a key role in shaping regulatory strategy for chemistry, manufacturing, and controls. The consultant ensures that regulatory submissions meet international standards and supports timely product approvals.
What We’re Looking For
We seek a detail-oriented professional with deep knowledge of global CMC regulations. The ideal candidate has a track record of successful regulatory submissions and can navigate complex regulatory landscapes.
Does not offer visa sponsorship
