Senior Regulatory Associate – CMC Authoring | Indegene Bengaluru
- Senior Regulatory Associate – CMC Authoring | Indegene Bengaluru
- Company Overview
- Job Role & Responsibilities
- CMC Regulatory Authoring
- Submission & Lifecycle Management
- Client & Cross-Functional Collaboration
- Quality & Compliance Oversight
- Eligibility / Qualifications
- Educational Background
- Experience
- Required Skills
- Location & Employment Details
- Application Process
- Frequently Asked Questions (FAQs)
- 1. What is CMC in regulatory affairs?
- 2. Is prior experience in US FDA or EMA submissions mandatory?
- 3. Does this role involve client interaction?
- 4. Is eCTD experience required?
- 5. What level of experience is required?
- Summary
Senior Regulatory Associate – CMC Authoring | Indegene Bengaluru
Indegene is hiring for the position of Senior Regulatory Associate – CMC Authoring in its Regulatory Affairs division at Bengaluru, Karnataka. This is a full-time, on-site opportunity for experienced professionals with 4–8 years of hands-on experience in CMC regulatory writing, eCTD submissions, and global regulatory documentation. The role is ideal for candidates with strong exposure to US FDA, EMA, ICH, and global regulatory frameworks who are looking to advance their career in regulatory operations and pharmaceutical compliance.
With increasing global demand for accurate CMC documentation, regulatory submission management, and lifecycle maintenance of drug products, skilled regulatory professionals play a critical role in accelerating approvals and ensuring compliance across international markets.
Company Overview
Indegene is a global life sciences commercialization partner that supports pharmaceutical, biotechnology, and healthcare companies in driving compliant product development and regulatory success. The organization works closely with leading pharma companies across the US, EU, and emerging markets to deliver regulatory affairs services, medical writing, digital transformation solutions, and regulatory operations support.
With deep domain expertise in Chemistry, Manufacturing, and Controls (CMC), Indegene helps clients streamline NDA, ANDA, MAA, and BLA submissions through structured authoring, automation platforms, and eCTD publishing solutions. The company is recognized for combining scientific expertise with technology-driven regulatory solutions, making it a trusted partner in global drug development and lifecycle management.
Working at Indegene offers exposure to international regulatory environments, cross-functional collaboration, and high-impact client-facing projects that directly influence product approvals and market access strategies.
Job Role & Responsibilities
As a Senior Regulatory Associate – CMC Authoring, you will be responsible for leading the preparation, review, and lifecycle management of CMC regulatory documents for global submissions. This role requires deep scientific understanding and regulatory knowledge to ensure compliant, accurate, and submission-ready documentation.
CMC Regulatory Authoring
- Independently prepare and review Module 2.3 and Module 3 sections covering drug substance and drug product information including manufacturing processes, formulation details, specifications, stability data, and quality controls.
- Author CMC content for NDA, ANDA, MAA, BLA, and submissions for US, EU, ROW, and AFM markets.
- Ensure compliance with ICH guidelines, FDA regulations, EMA requirements, and WHO standards.
- Maintain scientific accuracy, clarity, consistency, and alignment with global regulatory expectations.
Submission & Lifecycle Management
- Support initial filings, variations, amendments, and post-approval lifecycle submissions.
- Ensure regulatory documentation aligns with client SOPs and global submission strategies.
- Demonstrate expertise in eCTD authoring, publishing workflows, and document management systems.
- Manage structured content reuse strategies and support automation initiatives in CMC authoring.
Client & Cross-Functional Collaboration
- Coordinate with CMC teams, Quality Assurance, Regulatory Affairs, Manufacturing, and Publishing teams to gather accurate technical data.
- Participate in client calls for content discussions, project updates, and submission timelines.
- Ensure high client satisfaction through quality deliverables and adherence to timelines.
- Perform Root Cause Analysis (RCA) and develop Corrective and Preventive Actions (CAPA) when required.
Quality & Compliance Oversight
- Maintain strong understanding of internal SOPs, client-specific processes, and evolving regulatory guidelines.
- Ensure high standards of regulatory compliance in line with global market requirements.
- Deliver submission-ready documents within tight deadlines while maintaining accuracy and completeness.
This position directly contributes to global drug approval pathways, regulatory risk mitigation, and compliance-driven pharmaceutical development.
Eligibility / Qualifications
Educational Background
MBBS, PhD (Life Sciences), MDS, BDS, MPharm, PharmD
Relevant Specializations: Pharmaceutical Sciences, Clinical Research, Regulatory Affairs, Medicinal Chemistry, Biotechnology, Microbiology, Pharmacology, Industrial Pharmacy, Pharmaceutical Analysis.
Experience
- 4–8 years of experience in CMC regulatory writing and authoring.
- Strong exposure to global regulatory submissions including US FDA, EMA, ICH guidelines.
- Experience working in client-facing or service-based regulatory environments.
- Hands-on experience with eCTD authoring and publishing systems.
- Exposure to digital authoring platforms, structured content management, or regulatory automation tools is an advantage.
Required Skills
- Strong scientific writing and analytical skills.
- Excellent written and verbal communication abilities.
- Advanced proficiency in MS Word, Excel, and PowerPoint.
- Experience in document management systems and workflow approvals.
- Good understanding of global regulatory operations and lifecycle management processes.
- Ability to work effectively in cross-functional teams and manage multiple deliverables.
Location & Employment Details
- Location: Bengaluru, Karnataka, India (On-site)
- Employment Type: Full-time
- Experience Level: Mid to Senior Level (4–8 Years)
Salary details are not publicly disclosed. Compensation is typically aligned with industry standards for senior regulatory affairs and CMC documentation professionals in India’s pharmaceutical and life sciences sector.
Application Process
Interested candidates can apply through the official LinkedIn job listing:
Apply Here: https://www.linkedin.com/jobs/view/4378818825/
Applicants are advised to ensure that all professional and academic details are accurately updated before submission.
Frequently Asked Questions (FAQs)
1. What is CMC in regulatory affairs?
CMC stands for Chemistry, Manufacturing, and Controls. It covers detailed documentation related to drug substance, drug product manufacturing, formulation, stability, and quality compliance required for regulatory approval.
2. Is prior experience in US FDA or EMA submissions mandatory?
Yes, candidates must have strong exposure to US FDA, EMA, ICH, and other global regulatory frameworks for this role.
3. Does this role involve client interaction?
Yes, the position requires direct interaction with global clients for content discussions, project updates, and submission coordination.
4. Is eCTD experience required?
Yes, hands-on experience in eCTD authoring and publishing workflows is essential.
5. What level of experience is required?
Candidates must have 4–8 years of relevant experience in regulatory CMC authoring and review.
Summary
| Company | Indegene |
|---|---|
| Vacancies | Senior Regulatory Associate – CMC Authoring |
| Required Education | MBBS, PhD (Life Sciences), MDS, BDS, MPharm, PharmD |
| Experience | 4–8 Years in CMC Regulatory Authoring and Global Submissions |
To apply for this job please visit www.linkedin.com.
