Pulse has established a state of the art manufacturing facility at Roorkee, Uttarakhand and the same is certified for WHO GMP, which not only produces products for its
in-house requirements but also for some of the most reputed Pharmaceutical companies like Abbott, Glenmark, Sanofi Aventis, Akesis Pharma, Meyer Organics, SH Pharma,
MSN Labs & Biological-E etc.

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Position: AGM/Sr Manager – Regulatory Affairs

Location: Madhapur, Hyderabad, Telangana

Job Description:

  • Experience in end to end RA activates
  • Strong knowledge of Regulatory Requirements
  • Regulatory filings & registrations
  • Cross-functional capabilities

Required Candidate profile

  • Handling the ROW market (APAC, CIS, LATAM, and AFRICA & GCC) and planning for timely submissions of the dossier.
  • Post-approval changes notification/variation filings to customer/MOH
  • Preparation of SOPs for the regulatory affairs department
  • Final review of the Product Registration Dossiers as per the country’s guidelines/clients requirements for various countries in ROW
  • Coordinating with various departments like QC, QA, R&D, Production, warehouse, Packaging and Export for required documents in connection to the preparation of dossiers/queries response/Additional requirements and studies

Qualification: B.Pharma/M.Pharma

Experience: 10-15 Years

Salary: Negotiable

Contact Details:

Krishna Mohan T
+91-9121022965
krishnamohant@pulsepharma.net

 

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