
Senior Regulatory Compliance Expert
3 days ago
Job Overview
We are seeking a highly skilled Regulatory Affairs Specialist to oversee the preparation and submission of regulatory dossiers ensuring compliance and timely approvals.
This role is pivotal in managing activities pertaining to new application submissions for Europe through DCP MRP NP.
Collaboration with European Regulatory authorities and internal teams will be essential to ensure the regulatory compliance for new applications.
Responsibilities
- Should have an regulatory experience in Europe market new application submissions.
- Preparation review and submission of new applications through DCP MRP NP for EU.
- Preparation and review of m1 documentation in-line to the m2-5 documents.
- Preparation of product information and review of artworks to ensure regulatory compliance.
- Direct Interaction with EU regulatory authorities.
- Handling of deficiencies and timely response to regulatory agencies.
- Good interpersonal skills with command on English language to communicate with Regulatory agencies IL Customers.
- Providing regulatory guidance/regulatory strategies to IL partner and other cross functional teams.
- Support the manufacturing sites during Regulatory audits.
- Performing other tasks and duties assigned by the immediate supervisor.
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