Regulatory Affairs Specialist

3 days ago


Bangalore, India Biocon Full time

Role - Formulation Regulatory Affairs - for Peptide products or Injectables Level - Deputy Manager/ Associate Manager Required Education/Ex p: Experience Req.: 8 - 12 yrs. Qualification: - M. Pharma / M.Sc. Key Role- Formulation Regulatory Affairs for Peptide products or Injectables Responsibiliti es: Drafting controlled correspondences, pre-development meetings and scientific advices for seeking regulatory feedback on various topics from different Health-Agencies especially for peptides products & Injectables. Prepare a regulatory submission strategy, checklist for administrative and technical documents for each submission considering country specific requirements for peptide products. Compilation of CTD sections and supporting documents from Module 1 to 5 with respect to each Health-Agencies and ensure the regulatory compliance to most current requirements. Prepare a draft response to queries raised by the Health agencies / Business partner with supporting updated documents. Ensure to respond within the prescribed timelines. Review and provide Technical inputs during product life cycle starting from developmental documents, drug-device combination product and clinical/non-clinical proposals. Co-ordinate with all cross-functional teams and regularly updating the status tracker/checklists and keep updating reporting head. Any other responsibilities vested by reporting head based on requirements. Required sk ills :- Hands on expertise of handling Peptide or Injectable products. Peptide Regulatory Exp will be prefered more. Well versed with regulatory gui delines. Candidates with relevant exp., kindly share CVs to apply on :- Kindly mention below details while sharing CV :- Total Exp? Current CTC? Handling exp of Peptide Regulatory or not? Notice Period? Ready to work in Bangalore (onsite) ? (5 Days working)



  • bangalore, India Biocon Full time

    Role - Formulation Regulatory Affairs - for Peptide products or InjectablesLevel - Deputy Manager/ Associate ManagerRequired Education/Exp:Experience Req.: 8 - 12 yrs.Qualification: - M. Pharma / M.Sc.Key Role- Formulation Regulatory Affairs for Peptide products or InjectablesResponsibilities:- Drafting controlled correspondences, pre-development meetings...


  • bangalore, India NexorTest Technologies Full time

    Location: Bengaluru / Hybrid Experience: 5 - 8 yearsOverall Package: 8 - 10 LPARole Summary:The Regulatory Affairs senior specialist will be responsible for planning, preparing, and managing regulatory submissions and compliance activities for medical devices under CDSCO (India), EU MDR, and US FDA frameworks. The role involves working cross-functionally...


  • Bangalore, India NexorTest Technologies Full time

    Location: Bengaluru / Hybrid  Experience: 5 - 8 years Overall Package: 8 - 10 LPA Role Summary: The Regulatory Affairs senior specialist will be responsible for planning, preparing, and managing regulatory submissions and compliance activities for medical devices under CDSCO (India), EU MDR, and US FDA frameworks. The role involves working...


  • bangalore, India NexorTest Technologies Full time

    Location: Bengaluru / Hybrid  Experience: 5 - 8 years Overall Package: 8 - 10 LPA Role Summary: The Regulatory Affairs senior specialist will be responsible for planning, preparing, and managing regulatory submissions and compliance activities for medical devices under CDSCO (India), EU MDR, and US FDA frameworks. The role involves working...


  • bangalore, India Biocon Full time

    Role - Formulation Regulatory Affairs - for Peptide products or InjectablesLevel - Deputy Manager/ Associate ManagerRequired Education/Exp:Experience Req.: 8 - 12 yrs.Qualification: - M. Pharma / M.Sc.Key Role- Formulation Regulatory Affairs for Peptide products or InjectablesResponsibilities:Drafting controlled correspondences, pre-development meetings and...


  • bangalore, India Varex Imaging Corporation Full time

    Varex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the...


  • bangalore, India Varex Imaging Corporation Full time

    Varex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the following:...


  • bangalore, India Biocon Full time

    Role - Formulation Regulatory Affairs - for Peptide products or Injectables Level - Deputy Manager/ Associate Manager Required Education/Ex p: Experience Req.: 8 - 12 yrs. Qualification: - M. Pharma / M.Sc. Key Role- Formulation Regulatory Affairs for Peptide products or Injectables Responsibiliti es: Drafting controlled correspondences, pre-development...


  • Bangalore, Karnataka, India AstraZeneca Full time

    Job Title International Regulatory Affairs Manager I Global Career Level D1 Introduction to role Within International Regulatory Affairs we take innovative regulatory approaches to bring life-changing medicines to patients in international markets We work across the AstraZeneca pipeline and business to accelerate regulatory approvals for new medicines in...


  • Bangalore, India Biocon Full time

    Role - Formulation Regulatory Affairs - for Peptide products or Injectables Required Education/Ex p: Experience Req.: 8 - 12 yrs. Key Role- Formulation Regulatory Affairs for Peptide products or Injectables Drafting controlled correspondences, pre-development meetings and scientific advices for seeking regulatory feedback on various topics from different...