Regulatory Affairs Associate

Job Description

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

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 :

Requirements

FDA