Biocon Biologics Released Job Openings

Biocon Biologics Released Job Openings On 30/05/2022.Biocon Biologics is a globally recognized, innovation-led organization that is enabling access to high quality, advanced therapies for diseases that are chronic, where medical needs are largely unmet and treatment costs are high.

Vacancy Details:

Biocon Biologics Recruiting Masters degree (Pharma or Life Sciences) Candidates with 10-18  Years of Experience for National Regulatory Affairs Manager Position.

Important Details :

• Location :Bangalore/Bengaluru( Bande Bommasandra )
• No of Vacancies:Not Disclosed by Recruiter
• Details of Salary: Not Disclosed by Recruiter
• Opening date for online Application:30/05/2022
• Mode of application :Online
  
• How To Apply:At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps

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Job Description/Skills Required

• Responsible for guiding various teams on regulatory requirements all stages of drug development, marketing and till post approval activities (product lifecycle management) including CMO site addition on LL basis.
• Provide regulatory guidance and support NRA/project teams on regulatory filing strategies, submission requirements, query responses, SEC preparation, testing, etc. for enabling faster submission & approvals for our applications.
• Responsible for compilation, submission, query management, getting approval, post-approval change management, life-cycle management of biological/biosimilar/medical device products.
• Provide guidance to NRA team members on latest regulatory changes and expectations of the Govt. Agencies ensure no queries to facilitate faster approvals.
• Responsible for review of dossier sections viz., CMC, non-clinical, clinical to ensure regulatory requirements are fulfilled
• Review applications / query responses before submission and provide comments/guidance to NRA team members
• Review, provide feedback for manufacturing changes, nonconforming materials reports, test protocols and reports to ensure regulatory compliance with Indian regulatory and applicable standards, and determine filing requirements.
• Review promotional and advertising materials, complaints, vigilance data and MDR reporting, if any.
• Responsible for sending testing samples / reference standards / cell lines / reagents to NIB/CDTL/IPC and follow-up for timely release of testing reports.
• Interactions with various Govt. / Regulatory officials for building / maintaining trust and obtaining timely approvals
• Keep track and monitor all latest gazette notifications, Amendments to Drugs & Cosmetic Act & Rules, GSR notifications, Circulars, Office orders being released by MoH&FW, CDSCO, NPPA, other Govt agencies. Updating the team and support in assessment of impact on our products / applications.

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