We are seeking experienced Regulatory Affairs professionals to support branded pharmaceutical products across development and the commercial lifecycle.
The role requires strong Global CMC expertise, with a focus on authoring and coordinating CMC sections for new registrations, post-approval changes, renewals, annual reports, and line extensions.
Responsibilities
* Author and coordinate CMC sections for regulatory submissions.
* Prepare responses to regulatory authority questions and perform quality reviews of CMC submissions.
* Evaluate global regulatory requirements, internal policies, and agreed timelines to ensure compliance.