Opportunity for Senior Manager-Regulatory Devices in Biocon

 

Biocon is a research-driven, global healthcare company with a strong matrix of capabilities along the biopharmaceutical value chain. Focusing on unmet medical needs in cancer, diabetes and inflammatory diseases, it offers novel therapies on a platform of affordable innovation.
Biocon together with group companies employs more than 2500 employees with approxmimately Rs 1,000 crore turnover and is expected to grow further during the current financial year.

Post: Senior Manager-Regulatory Devices - HC/JC/2197/12


Job Description:
1.Lead the team for regulatory affairs for devices.
2.Interact regularly with national and international regulatory bodies.
3.Work with Class II and Class III devices extensively.
4.Ensure accurate and regular filings with the US and EU authorities.
5.Manage regular US FDA audits in a GMP compliant manner.
6.Offer regulatory support to R&D team and other business verticals.
7.Utilise own exposure to injectibles to support product study and development.
8.Extensive experience with Class II and Class III injectables.
9.Has managed regulatory filings with international bodies earlier.
10.Well versed with technicalities involved in invasive devices.
11.Exposure to regulatory affairs of any invasive devices is must (stents/auto injections/insulin related, etc.


Candidate Profile:
1.Extensive experience with Class II and Class III injectibles
2.Has managed regulatory filings with international bodies earlier
3.Well versed with technicalities involved in invasive devices
4.Exposure to regulatory affairs of any invasive devices is must (stents/auto injections/insulin related, etc)

Additional Information:
Experience: 10-15 Years
Qualification: M.Pharm, Ph.D
Location:
Bangalore
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: QA
End Date: 27th Jan, 2012

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