RA Manager
About this role
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Skills you'll use
What you'll do
- Regulatory Compliance Leadership:
- -Ensure full regulatory compliance for R&D activities performed at the site.
- -Monitor, interpret, and implement evolving regulatory requirements and policy updates impacting R&D operations.
- -Assess potential business impact arising from regulatory non-compliance. Advise mitigations, and drive implementation of corrective/preventive actions to ensure sustained compliance.
Who can apply
- -Minimum 5+ years of Regulatory Affairs (India) experience with direct hands-on exposure to:
- · CDSCO interactions and submissions
- · State FDA operations and licensing
- · Regulatory audits/inspections and closure management
- -Pharma R&D experience is strongly preferred, with capability to support lab-based compliance environments (formulation/analytical/testing/sterility assurance scope as applicable).
- -Excellent regulatory writing and documentation skills with strong attention to detail and compliance mindset.
- -Strong coordination skills and ability to manage complex stakeholders across global and local teams.
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