The role will be accountable for all liaising activities including central, state and other relevant regulatory authority for EPD India products, including but not limited to liaison activities pertaining to Vaccines, FSSAI Approvals, subsequent NDA, Import & Registration, CDTL clearance, Clinical Trials, SAE and PSURs for Abbott products. The role will ensure timely approvals for all EPD product related applications submitted to central licensing authority and also handle any queries pertaining to these applications or other Abbott products.

Primary Job Function :

• Liaison with Authorities /officials to ensure timely approvals & availability of valid licenses, FSSAI approvals, for Vaccines
• To assure conformity of dossiers to the local statutory requirements.
• Provides project-specific regulatory services and coordination of these projects
• Review and evaluate technical and scientific data and reports required for submission
• Provide inputs on strategies for new drug applications, subsequent NDAs & other applications to be submitted by Abbott
• Support Pharmacovigilance activities pertaining to clinical trials and marketed products
• Implement, monitor and evaluate regulatory processes and systems for effective, efficient and compliant regulatory operation.
• Update stakeholders on changes in local regulatory environment and their impact on business continuity
• Propose modifications in processes and SOPs required by changing regulations and ensure compliance with the new regulations
• Build strong & healthy relationships with Authorities officials for FSSAI products and vaccines
• Represent Abbott at various industry platforms e.g. OPPI/CII/ ISCR
• Monitor applicable regulatory requirements; assure compliance with the company’s and external standards
• Liaises with Abbott local and global teams to support the business
• Develop strong partnerships with medical, manufacturing and marketing to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization

Education & experience:

• M. Pharm / M.Sc. or equivalent
• 10 Years of pharmaceutical regulatory experience with MNC or local company.
• Experienced liaison with CDSCO and State FDA, FSSAI.