Regulatory Affairs Team Leader

Regulatory Affairs Team Leader \Authoring.

Role detailed classification

Regulatory Affairs Authoring

Job Summary: We are seeking highly skilled andexperienced Life Sciences (LS) Regulatory Affairs (RA) TeamLeader (TL) \Authoring to join our LS Practice team. The successfulcandidate will be responsible for LS Regulatory Authoring and\/or otherassigned RA activities . This leadership role oversees a team of regulatorywriters focused on CMC (Chemistry, Manufacturing, and Controls) and Safetydocumentation . The Team Leader ensures strategic alignment, quality, andtimely delivery of regulatory documents for global submissions, while mentoringteam members and driving process improvements. The role will involve knowledgeof Global Regulatory Affairs guidelines, platforms and systems to undertakevarious assigned roles and responsibilities, included but not limited to belowdescribed activities. A Life Sciences Regulatory TL\/Writer are responsible forpreparing high\-quality documentation required for regulatory submissions ofdrugs, biologics, medical devices, or combination products. These professionalsplay a key role in translating complex scientific data into clear, compliant,and compelling regulatory documents. The writer ensures that all documentation complieswith global regulatory standards and supports submissions to agencies like theFDA, EMA, and other health authorities.

Key Responsibilities:

Life Sciences Regulatory Affairs TL Authoring plays acrucial role in ensuring compliance within the pharmaceutical, medical devicesand biotechnology industries by managing the assigned regulatory affairsactivities for regulatory submissions, health authority queries, approvals,variations, renewals\/ licence maintenance & regulatory compliancethroughout the product lifecycle. This role involves preparing, writingand reviewing regulatory documents, maintaining compliance with global standardsand regulations, and utilizing Regulatory systems to track and organizecritical data for various assigned activities.

Specific RA Authoring Team Leads activities:

CMC Writing Oversight

• Lead preparation of CMC sections for regulatory submissions (e.g., IND, NDA\/BLA, DMF, CTD)
  
• Review documents like:
  
  • Quality Overall Summary (QOS)
    
  • Drug Substance\/Product descriptions
    
  • Manufacturing process and control strategies
    
  • Stability data and validation reports
    
  • Ensure alignment with global regulatory requirements (FDA, EMA, ICH etc.)
    

    Safety Writing Oversight
    

    • Supervise creation of safety\-related documents:
      
      • Development Safety Update Reports (DSURs)
        
      • Risk Management Plans (RMPs)
        
      • Safety narratives and adverse event summaries
        
      • Safety sections of Investigator Brochures (IBs)
        
      • Collaborate with pharmacovigilance and clinical teams
        

        Team Leadership & Strategy
        

        • Act as primary interface between writing team and global regulatory functions
          
        • Provide strategic direction and prioritize deliverables based on business needs
          
        • Mentor, coach, and develop writing staff; conduct performance evaluations
          
        • Drive continuous improvement in writing processes and tools
          
        • Ensure compliance with internal SOPs and external regulatory guidelines
          

          
          

          1. Lead and mentor a team ofregulatory writers to timely deliver, fully compliant documents as per currentwriting formats of the respective health agencies\/ countries
          

          2. Oversee writing activities forglobal submissions (INDs, NDAs, BLAs, MAAs, 510(k), PMAs, CE Marking etc.)
          

          3. Ensure adherence to regionalregulatory guidelines (FDA, EMA, Health Canada, EU MDR) and internal SOPs
          

          4. Perform quality control (QC)checks and troubleshoot authoring\/ system issues
          

          5. Collaborate cross\-functionallywith Regulatory Affairs, Clinical, CMC, and IT teams
          

          6. Oversee RA tools and platforms(e.g., DMS, Lorenz DocuBridge, Veeva Vault, Extedo)
          

          7. Drive continuous improvementinitiatives improvement in workflows for regulatory processes and systemusability.
          

          
          

          8. Monitor KPIs and generate reportson submission timelines, system usage, and data quality.
          

          9. Stay current with evolvingregulatory standards and implement best practices
          

          10. Support audits and inspections by maintainingsubmission traceability and documentation integrity
          

          11. Train team members and stakeholders on writing highquality within the processes and tools
          

          Managing Productivity & Quality from RA authoringteam associate activities and undertake, as necessary:
          

          1 DossierPreparation and Submissions:
          

          Authoring\/ Preparing, finalizing CMC\/ Safety sections forvarious regulatory submissions, including drug master files (DMFs), EUMDR, CE Marking, FDA 510(k), PMA, INDs, NDAs, BLAs, MAAs, ANDAs and\/orCTAs and other documentation as per the current requirements of regulatoryauthorities like the US FDA, EMA, Health Canada, UK and Rest of the world (RoW)markets in electronic dossiers formats (eCTD, CTD\/ ACTD). Compilation andreview technical documents related to manufacturing, testing, andpackaging of drug substances, drug products, Biosimilars\/ Biotech and\/ormedical devices. Knowledge of electronic document management systems (DMS)workflows is essential.
          

          CMC Writing
          

          • Author documents such as:
            
            • Quality Overall Summary (QOS)
              
            • Drug Substance (DS) and Drug Product (DP) descriptions\/ specifications etc.
              
            • Stability protocols and reports
              
            • Manufacturing process descriptions
              
            • Risk matrices and instructions for use (IFU)
              
            • Collaborate with manufacturing, quality, and analytical teams to gather technical data
              
            • Support FDA meeting requests and background packages
              

              Safety Writing
              

              • Draft and review safety\-related documents including:
                
                • Development Safety Update Reports (DSURs)
                  
                • Risk Management Plans (RMPs)
                  
                • Safety narratives and adverse event summaries
                  
                • Safety sections of Investigator Brochures (IBs)
                  
                • Work closely with pharmacovigilance and clinical teams to ensure accurate safety reporting
                  

                  General responsibilities
                  

                  1. Compliance and Standards:
                  

                  Ensuring adherence to global regulatory guidelines such asICH, ICH\-GCP, GMP and managing product registration and maintenance acrossdifferent markets.
                  

                  2. Cross\-functional Collaboration:
                  

                  Working with various client teams (e.g., RA, QA,Development, Manufacturing, clinical, pharmacovigilance, medical writing etc.)to ensure timely and accurate regulatory submissions and ongoingcompliance. Monitor regulatory changes and advise internal teams onimplications for product development and lifecycle management. Support auditsand inspections by Notified Bodies and regulatory agencies by maintainingaccurate records and submission history.
                  

                  3. Data Management and Reporting:
                  

                  Maintaining accurate records of all regulatory activitiesand leveraging Document Management, Publishing and RIM tools to extractinsights and support decision\-making.
                  

                  4. Post\-Market Surveillance:
                  

                  Participating in activities related to ongoing surveillanceand management of active products.
                  

                  
                  

                  Qualifications & experience:
                  

                  • Preferably a Postgraduate degree in Pharmacy\/ Life Sciences, or a related field.
                    
                  • 6\-8 years in Regulatory CMC\/ Safety writing\/ review\/ Product Life Cycle Maintenance\/ Labelling etc., and including at least about 2 years\experience in leading RA authoring team(s).
                    
                  • Strong knowledge of global regulatory requirements (FDA, EMA, ICH guidelines) is a must with Deep understanding of CMC and safety documentation requirements
                    
                  • Good knowledge of CTD format and submission platforms is a must have requirement. Proficiency in Regulatory e\-Systems\/ Documentation e.g. Veeva Vault, eCTD, Lorenz, GlobalSubmit etc. Proven experience in requirement gathering, documentation, and stakeholder management, Familiarity with eCTD, IDMP, XEVMPD , and GxP compliance, Experience with CSV\/validation support is a plus.
                    
                  • Strong knowledge of industry standards and regulations related to Quality Management Systems (e.g., ISO 9001, ISO 13485, FDA & Global Health authority regulations).
                    
                  • Experience with other regulatory systems (e.g., ArisGlobal, Lorenz docuBridge, MasterControl) and knowledge of Veeva Vault Quality is an added advantage.
                    
                  • Excellent communication, collaboration, presentation and stakeholder management skills.
                    
                  • Excellent writing, editing, and project management skills for a Fast\-paced, deadline\-driven environment with high compliance standards
                    
                  • Strong analytical, attention to detail and problem\-solving abilities.
                    
                  • Stable track record in LS Regulatory domain in a Mid\-large Organisation.
                    
                  • Proficiency in MS Office, Regulatory work processes and good knowledge of Global Regulatory submission requirements especially USFDA, MHRA, EMA, APAC, GCC, LaAtam for Medical Devices and\/or Medicinal\/ Biotech products.
                    

                    Skills: Regulatory CMC, Safety Writing, Review,FDA,EMA, ICH guidelines,Regulatory Affairs Authoring
                    

                    
                    

                    
                    

                    
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