Opportunity to work in Naprod Lifesciences as Regulatory Affairs Manager

Naprod’s vision is to become a world class player in oncology through excellence in innovation, discovery of new manufacturing processes / drug delivery mechanisms and consistently high quality of production. We commenced operations in 1994 with the inauguration of our ultra-modern facility for the production of generics and formulations for oncology and other therapeutic applications. We are one of the pioneers in India in lyophilization.
We identified, very early, the need for achieving self - sufficiency in formulations as well as in Active Pharmaceutical Ingredients (APIs) , and our achievements reflect this focus. We launched our (APIs) in year 1994 & now have to our credit a number of new manufacturing processes & drug delivery mechanisms.

Posts: REGULATORY AFFAIRS Manager

Job Description:
1. MONITORING AND CHECKING OF REGISTRATION AND RE-REGISTRATION DOSSIERS OF FORMULATIONS INCLUDING PRESCRIPTION PRODUCTS, OTS PRODUCTS, SEMI- REGULATED COUNTRIES AND NON-REGULATED COUNTRIES.
2. SORTING OUT TECHNICAL QUERIES RECEIVED FROM AGENTS AND HEALTH AUTHORITIES OF RESPECTIVE COUNTRIES FOR REGISTRATION OF PRODUCTS.
3. FORTNIGHT PLANNING OF DOSSIERS.
4. CO-ORDINATION WITH QUALITY ASSURANCE, QUALITY CONTROL, R&D, PACKING, PRODUCTION FOR TECHNICAL DATA.
5. DISTRIBUTION OF WORK TO SUBORDINATES.
6. ENSURING PREPARATION OF DOCUMENTATION ACCORDING TO THE REQUIREMENTS OF MOH OF THE CONCERNED COUNTRY.
7. ENSURING EFFECTIVE AND PROMPT ATTENTION AND HANDLING OF QUERIES FROM MOH OF VARIOUS COUNTRIES.
8. CO-ORDINATING VARIOUS MANUFACTURING LOCATIONS AND LEGAL DEPARTMENT.
9. MAINTAIN THE REGISTRATION CERTIFICATE.
10. MAINTAIN THE RECORDS OF REGISTERED PRODUCTS FOR RENEWAL OF REGISTRATION..
11. CHECKING FOR ARTWORK DEVELOPMENT OF PACKING MATERIAL FOR PRODUCT.
12. LIAISONING WITH INTERDISCIPLINARY GROUPS SUCH AS R&D, PPIC, PRODUCTION, PURCHASE SO AS TO PRODUCTIVELY CONTRIBUTE TO THE MARKETING REQUIREMENTS.
13. IMPARTING TRAINING TO THE TEAM MEMBERS TO KEEP THEM ABREAST OF THE REGULATORY UPDATES.
14. RESPONSIBLE FOR SUBMISSION OF TECHNICAL TENDER DOCUMENTS FOR INTERNATIONAL AND DOMESTIC TENDERS.
15. REGULAR UPDATING, AND TRACK FOR PRESENTATION.
16. DMF DOSSIER ACTIVITY.
SHOULD HAVE SUCCESSFULLY UNDERGONE UK-MHRA AND ANVISA INSPECTIONS

Candidate Profile:
B. PHARM / M.PHARM WITH 8 TO 10 YEARS EXPERIENCE IN SIMILAR CAPACITY.
CANDIDATE WILLING TO RELOCATE IN MUMBAI ONLY NEED TO APPLY.

Additional Information:
Experience: 8-10 Years
Location: Mumbai
Education: B.Pharm, M.Pharm
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: DRA
End Date: 3rd dec, 2011