Leading pharma co. with huge range of products ranging from sterile preparation to oral solid dosage forms with international markets.
Post: Regulatory Affairs Manager-Semi & Non regulated markets (1 opening, Male Candidates Preferred)
Job Description:
-Knowledge of Regulatory requirement for different countries (For Regulated / Non regulated Market)
- 5-10 years experience in Regulatory related work.
-Knowledge of latest guidelines of all countries
-Good coordination skill with related depart.
Candidates should be well versed in preparation of pdt dossiers in ACTD / CTD formats. Self initiative taking. Pro Active. CANDIDATES MUST HAVE EXPERIENCE IN NON REGULATED AND SEMI REGULATED MARKET
Should Manage all activites related to Product registration.Coordination with QA and Production people for dossier requirement. Awareness of preparation of COAs, Specifications etc.
Checking of RM COA recd. From suppliers. And Finish product COA recd. etc
Candidate Profile:
Qualification: B.Pharm, M.Pharm, B.Sc, M.Sc
Experience: 5-10 yrs exp handling Semi/non regulated markets.
Male candidates shall be preferred on priority as visiting FDA offices shall be in concern.
Additional Information:
Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Experience: 5-10 yrs
Location: Andheri East, mumbai
Industry: Pharma/Biotech
Key Skills: DRA
Last Date: 16th Feb, 2014
If the position interests you, kindly send across your updated CV (word format) at aspsol.recruitments@gmail.com
Kindly mention your current CTC, expected CTC and notice period. Also enclose your photograph with the application
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