HLL Lifecare Limited, a Mini Ratna Central Public Sector Enterprise under the Ministry of Health & Family Welfare, Govt. of India is a global provider of high quality healthcare products & services. With state-of-the-art manufacturing facilities spanning across India, HLL is diversifying into vaccine manufacturing, lifecare services, sanitary napkins besides engaging in procurement consultancy, healthcare infrastructure development and facility management.
Post: ASSISTANT PLANT MANAGER (REGULATORY AFFAIRS) - (Permanent / Contract)- 1
Department
HLL Lifecare Limited has set up a new Oral Solid Dosage (OSD) manufacturing unit at Kanagala, Belgaum district, Karnataka for the manufacturing of Hormonal tablets in compliance with WHO standards. The products, which are planned for manufacturing in these Green-field Hormonal formulations Facility (UniPill block), will be exported to various countries. Candidate will be posted in Regulatory Affairs department of UniPill block at Kanagala Factory, Belgaum.
Tasks
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Preparation, scrutiny & presentation of various registration documentation & technical dossiers, as per the guidelines of various regulatory agencies like WHO, UNFPA, Stringent Regulatory Authorities (US, Japan & European Union) and rest of the World.
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Preparation & application of documents for getting Product licenses, Certificate of Pharmaceutical Product, Free Sale Certificate, Renewals etc. from the local Drug Regulatory Authorities.
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To keep track & update on the legislation & guidelines in all the regions in which the company wishes to launch its products.
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To co-ordinate with all the related departments in the company for the collection of data for compilation of product dossiers.
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To liaise between the Indian Drug Control Authority, international regulatory agencies and the company for licensing, registration documents & regulatory audits.
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To co-ordinate with the CROs in connection with the corresponding bio-equivalence studies carried out for various regulatory filings.
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To arrange the procurement of comparator products for carrying out Bio-equivalence studies.
Requirements
Maximum Age: 37 years as on 01/06/2014
Scale of Pay (For Regular Appointment): 12600 - 32500
Pay: Annual CTC 4.9 Lacks (approx.) at the minimum of the scale.
Consolidated pay range: (For Fixed Term Contract engagement): Rs. 20,000 to 32,000 per month (inclusive of all allowances & benefits)
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Post Qualification Experience:
Essential: Minimum 2 years relevant experience in handling regulatory affairs of a reputed Pharma company.
Desirable: Successfully filed dossiers for WHO & Stringent Regulatory Authorities like USFDA, MHRA, TGA, etc. Successfully faced regulatory audits for WHO & Stringent Regulatory Authorities like USFDA, MHRA, TGA.
Additional Information:
Experience: Min. 2 years
Education: B.Pharm, M.Pharm (Regulatory Affairs)
Reference Code: HLL/HR/051/2014
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
End Date: 18th June, 2014
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