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Friday, July 30, 2010

Regulatory Affairs Executive/Senior Regulatory Affairs Executives 9 Opening(s)

Summary

Experience:
2 - 7 Years
Location:
Mumbai
Compensation:
Rupees 2,50,000 - 6,00,000
Highly competitive CTC & benefits
Education:
UG - B.Pharma,B.ScPG - Post Graduation Not Required,M.Pharma - Pharmacy,M.Sc - Any Specialization
Industry Type:
Pharma/ Biotech/Clinical Research
Role:
Regulatory Affairs Mgr
Functional Area:
Healthcare, Medical, R&D

Desired Candidate Profile

  • The candidate should possess a minimum 2 years of Experience in Regulatory Affairs.
  • Should have worked with the CTD Dossier.
  • Variation filling experience will be an added advantage

     

Job Description

  •  Preparation and submission of dossiers in CTD/ACTD format for Europe, US and ROW
  • Quality compliance assessment of dossiers and plant documents
  • Post approval and renewal activities for Europe

Keywords: Regulatory Affairs, variations, renewals, PSURs, CMC, CTD, eCTD, module 3, MAA, EMEA, MHRA

Company Profile

Founded in 1998, Pharmalink Consulting has experienced rapid growth, expanding into every major geography to become the world’s largest independent Regulatory Affairs specialists.

The key to Pharmalink’s success lies in a straightforward, transparent approach combined with Regulatory experience of unrivalled depth.

Our network of over 2000 professionals worldwide provides all major Regulatory Affairs services in the key Healthcare verticals of Pharmaceuticals, Biotech, Clinical, Consumer Healthcare, Medical Devices, Nutraceuticals and Veterinary.

Pharmalink works with equal success in partnership with large multi-nationals, small start-ups, biotechs, CROs and device manufacturers.
Contact Details
Company Name:
Pharmalink Consulting Pvt
Executive Name:
Suprabha Naralkar
Address:
Pharmalink Consulting Pvt
Level 4 Dynasty Business Park
Andheri Kurla Road – Andheri East
Mumbai 400059
MUMBAI,Maharashtra,India 400059

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