Regulatory Affairs Team Leader

Regulatory Affairs Team Leader Authoring.

Role detailed classification

Regulatory Affairs Authoring

Job Summary: We are seeking highly skilled and experienced Life Sciences (LS) Regulatory Affairs (RA) Team Leader (TL) Authoring to join our LS Practice team. The successful candidate will be responsible for LS Regulatory Authoring and/or other assigned RA activities. This leadership role oversees a team of regulatory writers focused on CMC (Chemistry Manufacturing and Controls) and Safety documentation. The Team Leader ensures strategic alignment quality and timely delivery of regulatory documents for global submissions while mentoring team members and driving process improvements. The role will involve knowledge of Global Regulatory Affairs guidelines platforms and systems to undertake various assigned roles and responsibilities included but not limited to below described activities. A Life Sciences Regulatory TL/Writer are responsible for preparing high-quality documentation required for regulatory submissions of drugs biologics medical devices or combination products. These professionals play a key role in translating complex scientific data into clear compliant and compelling regulatory documents. The writer ensures that all documentation complies with global regulatory standards and supports submissions to agencies like the FDA EMA and other health authorities.

Key Responsibilities:

Life Sciences Regulatory Affairs TL Authoring plays a crucial role in ensuring compliance within the pharmaceutical medical devices and biotechnology industries by managing the assigned regulatory affairs activities for regulatory submissions health authority queries approvals variations renewals/ licence maintenance & regulatory compliance throughout the product lifecycle. This role involves preparing writing and reviewing regulatory documents maintaining compliance with global standards and regulations and utilizing Regulatory systems to track and organize critical 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 of regulatory writers to timely deliver fully compliant documents as per current writing formats of the respective health agencies/ countries

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

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

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

5. Collaborate cross-functionally with Regulatory Affairs Clinical CMC and IT teams

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

7. Drive continuous improvement initiatives improvement in workflows for regulatory processes and system usability.

8. Monitor KPIs and generate reports on submission timelines system usage and data quality.

9. Stay current with evolving regulatory standards and implement best practices

10. Support audits and inspections by maintaining submission traceability and documentation integrity

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

Managing Productivity & Quality from RA authoring team associate activities and undertake as necessary:

1 Dossier Preparation and Submissions:

Authoring/ Preparing finalizing CMC/ Safety sections for various regulatory submissions including drug master files (DMFs) EU MDR CE Marking FDA 510(k) PMA INDs NDAs BLAs MAAs ANDAs and/or CTAs and other documentation as per the current requirements of regulatory authorities like the US FDA EMA Health Canada UK and Rest of the world (RoW) markets in electronic dossiers formats (eCTD CTD/ ACTD). Compilation and review technical documents related to manufacturing testing and packaging of drug substances drug products Biosimilars/ Biotech and/or medical 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 as ICH ICH-GCP GMP and managing product registration and maintenance across different 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 ongoing compliance. Monitor regulatory changes and advise internal teams on implications for product development and lifecycle management. Support audits and inspections by Notified Bodies and regulatory agencies by maintaining accurate records and submission history.

3. Data Management and Reporting:

Maintaining accurate records of all regulatory activities and leveraging Document Management Publishing and RIM tools to extract insights and support decision-making.

4. Post-Market Surveillance:

Participating in activities related to ongoing surveillance and 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 ReviewFDA EMA ICH guidelinesRegulatory Affairs Authoring