At Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche Diagnostics India, with a sales turnover of INR 150 crores, nurtures an open, flexible and challenging work environment, which allows for rapid career progression. Favored by its geographic location in the heart of Europe, the Basel area is one of the most dynamic economic regions in Switzerland — a great place to live and work.
Post: Executive - Regulatory Affairs
Job Description
1. Preparation of regulatory documents e/g. DI, DII, DMF, PE Dossier, RTQ etc wtih compilation of dossier, review regulatory application & submission of all required application pertain to Roche Diagnostics with full responisbility, accountabiilty.
2. Understanding & interpretation of Law & the Local regulatory requirment and implementing same in India submission with compliacne for Roche Products.
3. Responsibility for close coordination & regular follow-up with the Regulatory Authority for timely obtaining of all approvals.
4. Coordination with global regulatory team, local BA & other functions, required for regulatory submissions at India FDA.
5. Close monitoring of any changes in local & global regulatrions and communicating same within the department.
6. Responsible for regulatory activity with compliance and maintaing reputation of the organisation before authorities.
7. Respecting & following all SOP / system implemented withing the department and organisation.
Candidate Profile
Education: Post Graduate
Experience- 4-5 years in handling regulatory documentation, registration and licensing of drugs / devices
Additional Information:
Job ID: 2958365503
Qualification: Post Graduate
Location: Delhi
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: DRA
End Date: 23th December, 2014
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