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Wanted Manager - Drug Regulatory Affairs in Mylan Pharma

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Mylan is one of the world’s leading generics and specialty pharmaceutical companies, providing products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios, which is regularly bolstered by an innovative and robust product pipeline. With a workforce of more than 16,000, Mylan has attained leading positions in key international markets through its wide array of dosage forms and delivery systems, significant manufacturing capacity, global commercial scale and a committed focus on quality and customer service.

Post: Manager - Drug Regulatory Affairs

Job Description:
Liaison with Drug Regulatory Authorities
• To co-ordinate with drug authorities for the registration of drugs/ renewal of certificates.
• To provide periodic update of the interactions with the authorities.
• Maintain a record of existing licences & dates for renewal of each.
• Prepare a framework with timelines for the registration of new products.
• To review and approve the artwork for label and cartons
• To prepare the prescribing information and abbreviated prescribing information for the products

Major Accountabilities
• Develop good communication network with drug regulatory authorities
• Keep track of existing licences & apply for renewals well in time.
• Have complete understanding of the drug laws existing in the country.
• Develop & comply with local SOP

Candidate Profile:
To co-ordinate with drug authorities for the registration of drugs/ renewal of certificates.
Hands on experiance for domestic market.
Develop good communication network with drug regulatory authorities.

Additional Information:
Experience: 5-10 years
Location:
Mumbai
Education: B.Pharm, M.Pharm, M.Sc
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: DRA
End Date: 25th Feb, 2012

THIS JOB IS EXPIRED !

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