Senior Regulatory Associate - CMC Authoring

About the Role

The Senior CMC author/reviewer is responsible for leading the authoring, review, and lifecycle management of high-quality CMC regulatory documents (Module 2.3 and Module 3; detailing the drug substance and product, covering manufacturing, formulation, stability, and quality controls) to support global regulatory submissions. This role plays a key part in driving CMC authoring automation, ensuring regulatory compliance, consistency, and timely submissions across US, EU, ROW and/or AFM markets.

Responsibilities

• Without guidance from senior members of the writing staff, prepare/review CMC sections (Module 2.3 and Module 3; detailing the drug substance and product, covering manufacturing, formulation, stability, and quality controls) for initial filings and post-approval submissions across US, EU, ROW and/or AFM markets.
• Author and review CMC content for NDA, ANDA, MAA, BLA, and ROW submissions in line with regional regulatory expectations.
• Ensure scientific accuracy, clarity, consistency, and alignment with regulatory guidelines (ICH, FDA, EMA, WHO).
• Co-ordinate with relevant team functions including CMC, QA, Regulatory Affairs, Publishing, and Manufacturing teams to obtain accurate, appropriate information.
• Conducting regular client calls for content-related discussions as well as for project status updates and delivery.
• Responsible for high client satisfaction for all deliverables with regard to quality and accuracy, timelines, and efforts.
• Interacting with clients and follow-up till finalization.
• Performing RCA when required with the team and preparing CAPA.
• Work with internal stakeholders for project execution and actively participate in team meetings.
• Ensure high standards of regulatory compliance as per client requirement.
• Maintain knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines.
• Demonstrate ability to deliver timely, compliant submissions under tight deadlines.
• Experience with eCTD authoring and publishing environments.
• Exposure to content reuse strategies and data-driven regulatory authoring.
• Experience working in client-facing or service based regulatory environment.

Qualifications

• MBBS/PhD/MDS/BDS/MPharm/PharmD

Experience

• 4-8 Years

Required Skills

• Excellent communication skills (oral and written)
• Experience in authoring and/review of CMC regulatory documents
• MS Office (Excel and PowerPoint)
• Good knowledge of regulatory guidelines/requirements and other regional guidelines
• Very good medical/pharma/scientific knowledge that can be applied in developing/updating CMC regulatory submission documents
• Good knowledge of Regulatory affairs/Regulatory operations in US/EU/ROW/AFM markets
• Good knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management
• Client-specific project delivery process.
• Comfortable working on cross-functional teams with the ability to drive document content
• Expert authoring in MS Word, understanding of MS Word functionality
• Experience working in document management systems; managing workflows eApproval/signatures
• Flexibility in adapting to new tools and technology
• Hands-on experience or strong exposure to CMC authoring automation, structured content or digital authoring platforms and prior experience leading or supporting automation or digital transformation projects in Regulatory CMC is a plus.