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Wednesday, October 27, 2010

Head Regulatory Affairs- www.pharmanaukri.info

Summary

Experience:
10 - 12 Years
Location:
BADDI HP
Compensation:
commensurate with the best in the industry
Education:
UG - B.Pharma - PharmacyPG - M.Pharma - Pharmacy
Industry Type:
Pharma/ Biotech/Clinical Research
Role:
Drug Regulatory Dr.
Functional Area:
Healthcare, Medical, R&D

Desired Candidate Profile

1.10 Yrs – 12 Yrs, WITH 5 YEARS EXPERIENCE IN THE SAME CAPACITY.

2.B. Pharmacy/M. Pharmacy.

3.Regulatory Affairs

Job Description

1. MONITORING AND CHECKING OF REGISTRATION AND RE-REGISTRATION DOSSIERS OF FORMULATIONS IN SEMI- REGULATED COUNTRIES AND NON-REGULATED COUNTRIES.

2. DMF DOSSIER ACTIVITY

3. REVIEW OF DOSSIERS, REGULATORY DOCUMENTS, AND RESPONSE TO DEFICIENCIES RECEIVED FROM AGENTS AND HEALTH AUTHORITIES OF RESPECTIVE COUNTRIES FOR REGISTRATION OF PRODUCTS AND GUIDE TEAM MEMBERS.

4. CO-ORDINATION WITH QUALITY ASSURANCE, QUALITY CONTROL,

R&D, PACKING, PRODUCTION FOR TECHNICAL DATA.

5. APPROVING FOR ARTWORK DEVELOPMENT OF PACKING MATERIAL

FOR PRODUCT.

6. LIAISONING WITH INTERDISCIPLINARY GROUPS SUCH AS R&D, PPIC, PRODUCTION, PURCHASE SO AS TO PRODUCTIVELY CONTRIBUTE TO THE MARKETING REQUIREMENTS.

7. LIAISE WITH Govt. REGULATORY AGENCIES, PARTNERS, CUSTOMERS, AGENTS

8. RESPONSIBLE FOR SUBMISSION OF TECHNICAL TENDER DOCUMENTS FOR INTERNATIONAL AND DOMESTIC TENDERS.

9. ENSURING GOOD REGULATORY PRACTICES ARE FOLLOWED WITHIN THE TEAM AND ALSO PROPER TRAINING IS PROVIDED AMONGST THE TEAM MEMBERS.

Keywords: regulatory, M.pharma, B.pharma, pharma, labs, healthcare, medical, R&D.

Company Profile

ADLEY FORMULATIONS was incorporated in 1990, is a leading & dynamic pharmaceutical company, marketing products from a wide range of therapeutic areas including cardiovascular, anti-infective, CNS, anti-inflammatory, oncology, anti-diabetic, analgesic, dermatology, respiratory, and Gynec products.

In the last 20 year’s journey ADLEY has emerged as a niche player in the Pharma industry by establishing itself as a strong domestic player, having WHO GMP & ISO 9001:2000 certifications. 

For last three years Adley has focused its attention on Anti Cancer products with a strong pipe line of new molecules. Adley has specialized in early identification, development and introduction of new generation medicines for life threatening diseases through its strong R & D team.

Adley Group has firm determination to cross sales of Rs.100 crores by end of 2013 by significant exports of Oncology products in Regulatory and Non-regulatory markets.

Adley not only offers just about vertical growth in career but also enhancing true competence. It is about trust, performance & respect for each other.
Contact Details
Company Name:
Adley Group
Executive Name:
Mr.Akhil Chopra
Address:
Adley Group
SCO-915
2nd Floor
NAC, Mani Majra
CHANDIGARH,Chandigarh,India 160101
Telephone:
0172258548-09316790665

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