Job Summary:
The Sr. Regulatory Affairs Specialist plays a critical role in ensuring regulatory compliance and supporting cross-functional teams in the preparation, submission, and tracking of regulatory documentation. This position requires strong collaboration, communication, and analytical skills to support product development, market access, and post-market activities in alignment with global regulatory requirements.
Responsibilities:
- Act as a Regulatory Subject Matter Expert (SME) on various aspects and provide strategic guidance to other RA Staff and project team. Collaborate with quality, clinical, legal, commercial, and reimbursement teams to align regulatory strategies.
- Identify regulatory submission and approval requirements, and develop…
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