Our Client, a globally recognized leader in healthcare innovation, is seeking a Senior Regulatory Affairs Specialist. The successful person will manage regulatory activities and projects, develop regulatory strategies for new products, and handle submissions to regulatory authorities.
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)
* 3-5 years of Regulatory/CMC authoring experience in a Pharmaceutical company
* New market access filing and post approvals experience
* Experience liaising with Contract Manufacturers
* 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