Experience:
4 - 8 Years
Location:
Mumbai
Compensation:
No constrain for the right candidates. PL MAIL CV IN WORD DOC FILR FORMAT ONLY with current CTC.
Education:
UG - B.Pharma - Pharmacy;B.Sc - Chemistry
PG - M.Pharma - Pharmacy;M.Sc - Chemistry
Industry Type:
Pharma/ Biotech/Clinical Research
Functional Area:
Healthcare, Medical, R&D
Posted Date:
13 Nov
Job Description
The incumbent shall be responsible for planning and coordinating of regulatory submissions necessary to support clinical trials and product registration.
Actively co-ordinate the development and implementation of regulatory strategy (both CMC & non-clinical) for specific projects.
Coordinate all aspects of regulatory submissions for assigned projects, apply knowledge of regulatory requirements to the review of scientific documentation relevant to regulatory submissions and actively contribute to the development and implementation of regulatory strategy for assigned projects.
Provide expert technical writing input for CMC technical reports and CMC sections of INDs and CTAs. Manage the planning and coordination of clear and effective regulatory CMC submissions on assigned projects, ensure the alignment of regulatory CMC strategy with project and company objective Recommend regulatory CMC policies to ensure adherence to global regulatory CMC requirements for assigned projects.
Actively co-ordinate the development and implementation of regulatory strategy (both CMC & non-clinical) for specific projects.
Coordinate all aspects of regulatory submissions for assigned projects, apply knowledge of regulatory requirements to the review of scientific documentation relevant to regulatory submissions and actively contribute to the development and implementation of regulatory strategy for assigned projects.
Provide expert technical writing input for CMC technical reports and CMC sections of INDs and CTAs. Manage the planning and coordination of clear and effective regulatory CMC submissions on assigned projects, ensure the alignment of regulatory CMC strategy with project and company objective Recommend regulatory CMC policies to ensure adherence to global regulatory CMC requirements for assigned projects.
Desired Candidate Profile
MPharm/ MSc-Chem/Bio-Chem with relevant experience, in reputed pharmaceutical company
Company Profile
For a person seeking challenging career opportunity, the company offers an invigorating environment conducive to high levels of performance, besides a competitive remuneration package.
The company is Research & Development based one of the fastest growing Indian pharmaceutical companies with an annual growth in far exceeding the industry growth.
It has a STATE OF THE ART R & D CENTRE. The manufacturing plants are approved by the regulatory authorities from developed market.
Markets its products across the globe. Its mission is becoming a 'Research driven Global Pharmaceutical Company'.
The main focus of the company is to maintain a healthy top line growth as well as strengthening its international presence and capitalize on the generic opportunity in the developed markets.
The company is Research & Development based one of the fastest growing Indian pharmaceutical companies with an annual growth in far exceeding the industry growth.
It has a STATE OF THE ART R & D CENTRE. The manufacturing plants are approved by the regulatory authorities from developed market.
Markets its products across the globe. Its mission is becoming a 'Research driven Global Pharmaceutical Company'.
The main focus of the company is to maintain a healthy top line growth as well as strengthening its international presence and capitalize on the generic opportunity in the developed markets.
Contact Details
Company Name:
VISION M S -Excliusive Placements for pharma,Biotech,CRO & Chemical Companies
Executive Name:
A.I. Patel-Director
Address:
105,B-2,EKATA SOCIETY,SAIANAND PLAZA,
AGRA RAOD, NEXT TO BUS STOP ON AGRA ROAD.
CASTLE MILL,THANE-W
Mumbai - MAHARASTRA ,INDI 400601
Telephone:
91-022-25472347,25472348
Reference ID:
SR MGR REGUL
Keywords: IMPLEMENTING OF REGULATORY STRATERGY BOTH CMC AND NON - CLINICAL
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