Boehringer Ingelheim is a research-driven pharmaceutical company and one of the top 20 pharmaceutical firms worldwide. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally in over 100 countries and has more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine. In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 23.1% of its net sales.
Post : Senior Executive- Regulatory affairs
Job Description:
Accountabilities-
1. Clinical Trial applications and New drug applications:
To collect and compile the documents, dispatch the various applications as per the requirements Tracking and archiving the acknowledgments/dossier in hard and soft copies on common drive
CTA / NDA maintenance:
1) Updating the local pack insert
2) CMC updates, PSUR submissions
3) Registration certificate and Import license renewals
4) Clinical trial maintenance (e.g. Protocol amendments,Annual status report,test license renewals etc.)
Archive,track the details in tracker
Internal Compliance-
1) Regulatory Databases - Update internal databases like CPD3 (Regulatory tracking) and CTA database (CTA time lines tracking)
Update all the information and documents in database for initial application and subsequent variations
2) SLCI (Artwork management tool)
Perform all the steps required for new launch request and subsequent changes
3) LOS compliance
Experience & expertise-
1) System friendly and systemic approach. Awareness of Indian regulations.
2) Bachelors degree of pharmacy
3) Regulatory knowledge of domestic and international market
Other Information:
Experience: 3-5 year
Location: Mumbai
Education: M.Pharm, M.Sc
Industry Type: Pharma/biotech/Clinical research
Functional Area: Regulatory affairs
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