Regulatory Affairs SSC Team Lead(Biopharma)
3 weeks ago
About Our Client
Our client is a leading global healthcare company providing a diverse range of products in pharmaceuticals and Medical devices. They are a leading healthcare player in India as well.
Job Description
The role is a part of Global Shared Service Centre for based out of Gurugram and will be responsible for managing team of associates within Biopharma domain who will be working on enclosed below responsibilities :
Prepare,coordinate and submit the applications for variations and renewals to regulatory agencies within timelines. Oversee preparation and filing of high quality submissions. Provide expert strategy and guidance to the team in line with respective Service Line. Train the team on regular basis and continuously strive on performance improvement initiatives. Align with other Team leads across Service lines to ensure uniformity in operations. Ensure resolution of issues to ensure submissions are not impacted. Be updated with the agency requirements for regulatory data management and regional formats to ensure compliance. Act as a point of contact within the organisation for the delivery team for any requests and questions.
The Successful Applicant
An ideal candidate should have enclosed below skills and qualifications.
Bachelors degree in Lifesciences or related field, certificate in Regulatory affairs (not mandatory). 10 years of experience in Biologics, Biopharma organisations. Should have minimum 5 years of experience in managing teams. Fluent in English. Should have good knowledge of Regulatory Affairs in 1 or more markets (Europe, North America). Proven regulatory affairs knowledge and experience in filling of renewals and variations with different health authorities. Thorough understanding of agency guidelines pertaining to biologics. Prior experience in Shared Service Centre. This is a Hybrid role and person in this role should be comfortable working in Shift timings 12 PM - 9 PM. 3 PM - 11 PM. (Rotational shifts).-
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