To facilitate the increased demand for innovative application-based products, Sami Labs Limited (formerly known as Sami Chemicals & Extracts Limited) was set up in 1991 at Singasandra in Bangalore ( India ) as a research and development facility. Today the main thrust and focus of Sami is on new product development and market oriented research. To cater to the expanding global market, Sami Labs has presence and strategic alliances in USA, Europe, Japan, Australia, Middle East, South Africa, China, Vietnam, and Philippines. The global revenue of the company stood at USD 65 million (for 2009), with an employee strength of 150 people Internationally, more than 750 in India and over 110 scientists worldwide.
Post: Executive - Regulatory Affairs (Regulated, Semi & Non-Regulated Market)
Job Description:
1.To study and update Regulatory guideline of assigned countries and to prepare checklist / template for registration dossier.
2.To verify specification of excipients, active, finished product and packaging material and all required documents.
3.Application, review, co-ordination, follow-up of legal documents COPP, FSC etc. Preparation of all legal documents like applications to FDA for manufacturing license, product permission & DCG (I) submission.
4.Maintain Proper database w.r.t to master document dossier.
5.To collect and verify all technical documents and information from various departments at the manufacturing site.
6.To prepare and compile registration dossier as per the guidelines and checklist and submit to marketing to further submission to Regulatory authorities.
7. Regulatory support to various departments.
8. Review follow-up and co-ordination for registration samples /WS and impurities required for analysis purpose.
9. To prepare, review compile re-registration documents.
10. To prepare review, compile and co-ordination for documents required for company registration and Tender purpose.
11. To study, review variation guidelines of assigned countries and submit variation documents as per the guidelines.
12. To maintain and update Registration certificate /information in Regulatory data base.
13. Preparation of dossiers/replying to queries for various countries.
14. Checking of dossiers/artwork/technical documents.-Co-ordination with various departments
Candidate Profile:
1.Experience : 2-4 Years of experience in relevant field.
2.Experience in independently preparing legal applications & DCG(I) submission.
3.Experience in Regulatory Affairs in Asian, African & CIS countries & having knowledge of ACTD, CTD, ICH guidelines.
4.Proficiency in word,Excel and Power Point
5.Candidate will be responsible for preparation & review of DMF's for Regulated, Semi & Non-Regulated mkts.
6.Experienced in compilation of CTD dossiers are must.
Additionel Information:
Experiance: 2-4 Years
Location: Bangalore
Qualification: B.Pharm, B.Sc, M.Pharm, M.Sc
End Date: 29th June, 2012
Apply at, hr2@samilabs.com
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