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Head - Regulatory Affairs

By: Pharma Career | Views: 1404 | Date: 18-Feb-2011

Reporting to Managing DirectorHead of Regulatory Affairs and Quality Assurance/Control Dept.


Summary

Experience:
10 - 15 Years
Location:
Mumbai
Compensation:
Rupees 8,00,000 - 12,00,000
Education:
UG - B.Pharma - Pharmacy,B.Sc - Any Specialization,BVSC - Veterinary SciencePG - M.Pharma - Pharmacy,M.Sc - Any Specialization,MVSC - Veterinary Science
Industry Type:
Pharma/ Biotech/Clinical Research
Role:
Regulatory Affairs Mgr
Functional Area:
Healthcare, Medical, R&D
Posted Date:
17 Feb

Desired Candidate Profile

Key word: Product registration in India

Coordinate all product files (from different origins) in India, and ensure their life cycle in the frame of all the most updated text of law, legislation and internal procedures.

Delegation: Inform and validate each step with her/his hierarchy – collaborating with the Group Corporate Regulatory Affairs Dept.
Key word: Timing

Optimise all product registration files in India and ensure follow up all along the process, until launch approved by local authorities, in the frame of all local legislation, rules, regulation, and Corporate guidelines.

Delegation: Regularly report and validate each key step with her/his hierarchy for further action to be taken, liaising with Corporate Regulatory Affairs.
Key word: Group image building

Represent and build up corporate brand image amongst concerned local authorities, professional organisations and Universities.

Delegation: Reporting to her/his direct hierarchy
Key word: Product registration in export countries

Supervise the work of the technical and regulatory officer in charge of the registration of local Indian products in export countries.

Delegation: Reporting to her/his direct hierarchy and Corporate Regulatory Affairs
Key word: Quality Assurance/Control

Guide and supervise activities of quality assurance/control dept

Delegation: Reporting to her/his direct hierarchy
Key word: Regulatory environment intelligence

Ensure regulatory environment intelligence from all regulatory bodies in view of anticipating and/or implementing all necessary changes in due time. Regularly update all product registration files.

Delegation: Regularly update her/his hierarchy, for follow up and further action to be taken. A monthly executive summary is to be forwarded to the Corporate Regulatory Affairs Department.


Job Description

Reporting to Managing Director
Head of Regulatory Affairs and Quality Assurance/Control Dept.
Keywords: Head - Regulatory Affairs from Pharmaceutical company

Company Profile

Vetoquinol is European Multinational company having offices in 23 countries
Contact Details
Company Name:
VETOQUINOL INDIA ANIMAL HEALTH PVT LTD
Executive Name:
GOVIND BAGARAO
Address:
VETOQUINOL INDIA ANIMAL HEALTH PVT LTD
801, SIGMA BUILDING
TECHNOLOGY STREET,
HIRANANDANI BUSINESS PARK, POWAI,
MUMBAI,Maharashtra,India 400076
Telephone:
91-22-61322617

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