Regulatory Affairs Associate

Job Title: Regulatory Affairs Associate Authoring.

Role detailed classification

Regulatory Affairs Authoring

Job Summary: We are seeking highly skilled and experienced Life Sciences (LS) Regulatory Affairs (RA) Associate Authoring to join our LS Practice team. The successful candidate will be responsible for LS Regulatory Authoring and/or other assigned RA activities. 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 Writer is 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 Associate 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 to Regulatory Authoring

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.
  
• 4-6 years in Regulatory CMC/ Safety writing/ review/ Product Life Cycle Maintenance/ Labelling etc.
  
• Strong knowledge of global regulatory requirements (FDA EMA ICH guidelines) is a must
  
• 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.
  
• 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.