Role Description
We are seeking a skilled and experienced
Life Sciences (LS)
Regulatory Affairs (RA) Associate
– Publishing to join our LS Practice team. The successful candidate will be responsible for
LS Regulatory Publishing (Document/ Submission level Clinical/ CMC/ Administrative) 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.
Key Responsibilities
Life Sciences Regulatory Affairs Associate - Publishing plays a crucial role in ensuring compliance within the pharmaceutical, medical devices and biotechnology industries by managing the assigned regulatory affairs documents Collection. Compilation, Publishing & Submission activities for regulatory submissions, health authority queries, approvals, variations, renewals/ licence maintenance & regulatory compliance throughout the product lifecycle. This role primarily involves electronic document and submission level publishing of regulatory documents, maintaining compliance with global standards and regulations, and utilizing Regulatory systems to submit, track and organize critical data for various assigned activities.
Specific Regulatory Publishing activities
- Collation and publishing (Document level & submission level) of regulatory submissions (e.g., 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). Format and compile documents using publishing tools (e.g., Lorenz DocuBridge, Veeva Vault, Extedo etc.) to meet current agency-specific standards. Perform quality checks on submission packages to ensure compliance with SOPs and external regulatory guidelines. Manage submission timelines and coordinate with cross-functional teams including Regulatory Affairs, Clinical, and CMC. Archive and dispatch submissions electronically or in paper format, ensuring traceability and version control. Knowledge of global submission gateways (e.g., ESG, IRIS, CTIS) is essential.
- RA Associate Publishing is responsible for preparing, formatting, and submitting regulatory documents to global health authorities in compliance with electronic submission standards (e.g., eCTD, NeeS). This role ensures that submission packages meet technical and regulatory requirements and are delivered on time.
- Compile and publish electronic regulatory submissions (INDs, NDAs, BLAs, MAAs, 510(k), PMAs, ACTD etc.) using publishing tools
- Ensure documents meet eCTD standards, including bookmarks, hyperlinks, metadata, and validation
- Perform quality control (QC) checks on submission components and final packages
- Collaborate with cross-functional teams (Regulatory Affairs, Clinical, CMC, Quality) to gather and finalize documents
- Maintain submission archives and ensure version control and traceability
- Stay current with global regulatory guidelines (FDA, EMA, ICH, EU MDR) and publishing best practices
- Support audits and inspections by ensuring documentation integrity and readiness
- Troubleshoot formatting and technical issues in submission documents
- Contribute to process improvements and publishing workflow optimization
General Responsibilities
- Compliance and Standards:
Ensuring adherence to global regulatory guidelines such as ICH, ICH-GCP, GMP and managing product registration and maintenance across different markets.
- 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.
- 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.
- Post-Market Surveillance:
Participating in activities related to ongoing surveillance and management of active products.
Qualifications & Experience
- Graduate/ Postgraduate degree in Pharmacy/ Life Sciences, or a related field.
- 4-6 years in Regulatory Publishing- Document level & submission level with Proficiency in publishing software (e.g., Lorenz DocuBridge, Veeva Vault, Extedo).
- Strong knowledge of eCTD structure, regional submission formats, and validation tools
- 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.
- Adequate knowledge of industry standards and regulations related to Quality Management Systems (e.g., ISO 9001, ISO 13485, FDA & Global Health authority regulations).
- Experience with 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.
- 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.
- Familiarity with Microsoft Word, Adobe Acrobat, and document formatting standards is a must.
Skills
Regulatory Affairs, Publishing,Lorenz DocuBridge, Veeva Vault, Extedo,Quality Management System
