Opportunity for Senior Manager - RA - MAbs 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 - RA - MAbs - HC/JC/1838/12

Job Description:
a. Manage the entire team for regulatory affairs for MAbs
b. Interact regularly with national and international regulatory bodies
c. Act as the company spokesperson for this vertical with external and internal stakeholders to articulate the company position
d. Work closely with manufacturing, development and vendor partners
e. Overlook preparation of dossiers for filings
f. Ensure accurate and regular filings with the US and EU authorities
g. Manage regular US FDA audits in a GMP compliant manner
h. Offer regulatory support to R&D team and other business verticals
i. Responsible for risk assessment across businesses and manage risk accordingly
j. Devise regulatory strategies for product development

Candidate Profile:
a. Has managed regulatory filings with international bodies earlier
b. Has had minimum of 2 successful regulatory filings with international bodies
c. Demonstrated effective risk assessment ability in previous assignment
d. Very well spoken with excellent articulation and ability to connect to people

Additional Information:
Experience: 15-20 Years
Location: Bangalore
Education: M.Sc, Ph.D
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: QA
End Date: 19th December, 2012