Regulatory Affairs Manager
**Key Responsibilities:**
* Prepare and deliver high-quality CMC regulatory submissions for global agencies.
* Contribute to regulatory strategies and manage submission information, tracking commitments and timelines.
* Collaborate with stakeholders, provide consultation, and resolve regulatory issues.
* Manage submissions for new registrations, post-approval changes, renewals, and line extensions.
* Maintain global regulatory approvals and ensure timely responses to agency queries.
* Lead regulatory affairs-related projects.
Essential Criteria:
* Bachelor's/Graduate degree in a relevant science discipline (Biology, Chemistry, Pharmacy).
* Minimum 5 years of Regulatory/CMC authoring experience in a Pharmaceutical company is essential.
* New market access filing and post-approvals experience.
* Experience liaising with CMO's.
* Excellent written, oral communication, and project management skills.
Core Competencies:
* Action-oriented, detail-focused, and results-driven.
* Strong leadership, interpersonal, and presentation skills.
* Ability to manage multiple projects and respond effectively to change.