We are looking for a Regulatory Affairs CMC Senior Specialist to support the coordination and delivery of CMC regulatory dossiers and responses to Health Authority questions across multiple countries. You will work closely with Regulatory CMC colleagues, Technical SMEs, dossier authors and submission teams to coordinate deliverables, monitor timelines and ensure regulatory documentation is reviewed, approved and delivered on time.
Key Responsibilities
- Coordinate CMC regulatory dossier activities and responses to Health Authority questions across multiple countries.
- Track deliverables, response documents, timelines, dependencies and completion status.
- Provide regular project updates to internal and external stakeholders.
- Coordinate with Technical SMEs, Regulatory CMC teams and submission colleagues to ensure timely delivery of required documentation.
- Lead regular tracking meetings and follow up on actions, outstanding documents and deadlines.
- Coordinate document review and approval processes, including review timelines and comment resolution.
- Manage regulatory documentation within Veeva Regulatory Vault.
- Proactively identify potential timeline, documentation or delivery risks and escalate as appropriate.
- Support Technical CMC teams in interpreting and applying CMC regulatory requirements.
- Review CMC documentation provided by development and technical teams from a regulatory perspective.
- Support broader Regulatory CMC activities required for dossier preparation and delivery.
Qualifications
- Minimum 3 years of relevant experience in Regulatory Affairs, CMC or a related pharmaceutical environment.
- Experience coordinating projects or regulatory deliverables within a CMC environment.
- Good understanding of NDA/MAA dossier structures and CTD format.
- Understanding of pharmaceutical manufacturing and control principles.
- Degree in a relevant scientific or technical discipline.
- Strong organizational, project coordination and stakeholder-management skills.
- Ability to manage multiple activities, priorities and deadlines independently.
- Strong communication skills and ability to work effectively across global and cross-functional teams.
- Experience with regulatory document-management systems, particularly Veeva Regulatory Vault, is an advantage.
- Flexibility to collaborate across EU/UK and/or US East Coast working hours according to project needs.
About IQVIA
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
Mise en forme par Postule ·
Signaler un problème