Biocon Limited 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.

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We are driven by the belief that the pharmaceutical industry has a humanitarian responsibility to provide essential drugs to patients who are in need and to do so with the power of innovation. In line with this belief, Biocon has developed and commercialized a differentiated portfolio of novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets, as well as, generic formulations in the U.S. and Europe. We are a leading global player for biosimilars and APIs for statins, immunosuppressants, and other specialty molecules, with customers in over 120 countries.

We have built an employee-friendly environment for our gender-diverse workforce that is comparable to the best in the world. This has been validated once again by our position among the Top 20 Best Employers in the Biotech Industry as ranked by the prestigious Science magazine. We have been recognized for being a socially responsible organization with loyal employees who are providing global leadership in innovation.

Position: Dy Manager/Associate Manager – National Regulatory Affairs

Location: Bengaluru, Karnataka, India

Job Description:

  • Extensive knowledge about the Drugs & Cosmetic Act of India and NDCT Rules 2019.
  • Leading and guiding the team members and imparting training to the team members to keep them abreast of the regulatory updates.
  • Realistic experience & exposure with Indian Regulatory Authorities like CDSCO-HQ (DCGI), CDSCO Zonal & Subzonal offices, State Licensing Authorities, and RCGM/IBSC, GEAC, FSSAI & Testing Laboratories such as CDL & IPC.
  • Planning, execution, review, and timely submission of applications such as new drug, BA/BE, CT, Import/export applications; NOC for Test License, Import NOC for Dual-Use items and NOC for Export, CoPP, WHO-GMP) and handle inquiries from Regulatory authorities related product approvals.

  • Interact with various departments/teams (QA/QC/R&D/PM etc) to ensure filing of required regulatory documents on time as per regulatory norms.
  • Responsible for tracking the dossier review process from submission of high-quality dossier to timely submission of query responses till product launch.
  • Providing strategic input and operational timelines into the project plans as a core member of the project team during the drug development process, clinical and general project forums/meetings, and life cycle management projects.
  • Ensuring Good Regulatory Practices are followed within the team and also proper training is provided amongst the team members.
  • Maintain the registration certificate status and maintain the records of registered products for renewal of registration.
  • Maintain current knowledge of Indian regulatory requirements, guidance, and standards and applicable to company products.
  • Ability to work with different organization levels.
  • Good people management skills, excellent communication skills (Both verbal & written), understand the sense of urgency, the candidate should be self-starter, go & getter.
  • Other duties as assigned.

Qualification: M.Sc/M.Pharma

Experience: 8-10 years experience in Pharmaceutical Industry in National Regulatory Affairs.

Salary: Negotiable

Contact Details:

Ms. Pranjali Waghaye

pranjali.waghaye@biocon.com

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