Senior Regulatory Associate - CMC Authoring

Indegene; Bengaluru; On-site; INR 800,000 - 1,200,000; Full time

Job summary

A global regulatory consulting firm is seeking a Senior CMC author/reviewer in Bengaluru, India. This role involves leading the authoring and review of CMC regulatory documents to ensure compliance for submissions across various global markets. The ideal candidate will have at least 4-8 years of experience, a relevant educational background (MBBS/PhD/MDS/BDS/MPharm/PharmD), and excellent communication skills. Proficiency in regulatory guidelines and document automation is key for success in this role.

Qualifications

• 4-8 years of experience in a regulatory environment.
• Experience with eCTD authoring and publishing environments.
• Good knowledge of global/regional regulatory affairs.

Responsibilities

• Lead authoring and review of regulatory documents across multiple markets.
• Ensure compliance with regulatory guidelines.
• Coordinate with internal teams for project execution.

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

Very good medical/pharma/scientific knowledge

Good knowledge of Regulatory affairs in US/EU/ROW/AFM markets

Comfortable working on cross-functional teams

Expert authoring in MS Word

Flexibility in adapting to new tools and technology

Hands-on experience with CMC authoring automation

Education

MBBS/PhD/MDS/BDS/MPharm/PharmD

Tools

MS Word

MS Office

Job description

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
• Comfortable working on cross-functional teams with the ability to drive document content
• Expert authoring in MS Word, understanding of MS Word functionality
• 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.