Opening for post of Executive - Regulatory Affairs @ Virchow Healthcare

Virchow Healthcare Pvt. Ltd. is an International Marketing company under the flagship of Virchow Group. With global sales of more than USD $200 million, our mission is to provide world class, affordable and innovative medicines across the Globe.
Virchow Group is multidimensional company and comprise of six API and two Biotech/Pharma units. Incorporated in 1981, the flagship company of the group - Virchow Laboratories Limited is today the largest producer of Sulfamethoxazole in the world. Virchow Group services more than 80% of the worldwide Sulfamethoxazole requirement and also is a leading manufacturer of Sucralose, Ranitidine HCl, Cefixime, Cefpodoxime Proxetil, Cefuroxime Axetil, Cefdinir, and Cefprozil.

Post: Executive Regulatory Affairs

Job Description:
•Ensuring that company's products comply with the regulations of the ICH Guideline.
•keeping abreast of international legislation, guidelines and customer practices;
•collecting and collating a wide range of information, (preparation of dossiers as per country guideline);
•keeping up to date with a company's product range;
•preparing submissions of licence variations and renewals to strict deadlines;
•monitoring and setting timelines for licence variations and renewal approvals;
•writing clear, accessible product labels and patient information leaflets;
•advising scientists and manufacturers on regulatory requirements;
•undertaking and managing regulatory inspections;
•reviewing company practices and providing advice on changes to systems;
•specifying storage, labelling and packaging requirements

Candidate Profile:
Education qualification: B.Pharm / M. Pharm
with a minimum experience of atleast one year in pharma regulatory affairs (formulations)

Additional Information:
Experience: 1-2 years
Location: Mumbai
Education: B.Pharm, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
End Date: 29^th March, 2012