Job Title: Senior Regulatory Associate
Date Posted: 3 September 2025
Location: Bangalore, Karnataka, India (Office-based / Hybrid)
Company: Indegene
About Indegene:
Indegene is a global, technology-led healthcare solutions provider. Our mission is to make healthcare organizations future-ready through innovative, purpose-driven solutions. We offer global career growth for professionals who are bold, agile, and driven to make a difference.
At Indegene, you’ll:
Work at the convergence of healthcare and technology
Be mentored by top industry professionals
Be part of a fast-growing, entrepreneurial environment
Experience a career path defined by innovation, collaboration, and empathy
To explore more opportunities, visit: www.careers.indegene.com
Position Overview:
As a Senior Regulatory Associate, you will manage the preparation and submission of regulatory dossiers for EU and ASEAN markets. You will liaise with regulatory authorities, coordinate with internal teams, and provide strategic regulatory guidance.
Key Responsibilities:
Regulatory Dossier Preparation and Management:
Prepare and manage regulatory submissions (initial, post-approval, licensing) for EU and ASEAN markets
Author and compile regulatory documents, especially Module 1 documents (submission forms, cover letters, notifications, comparison tables)
Ensure submissions comply with applicable country-specific regulatory requirements
Coordinate with R&D, QA, and manufacturing teams to gather necessary documentation
Regulatory Strategy and Support:
Provide regulatory intelligence and guidance on CTA, drug/device/cosmetic/food registration requirements
Understand the regulatory framework for small and large molecules
Identify regulatory risks and propose mitigation strategies
Team Collaboration and Communication:
Participate in or lead cross-functional meetings with stakeholders
Communicate submission status, regulatory queries, and health authority requests with global counterparts
Track and maintain regulatory submission trackers
Coordinate with publishing teams for final dossier submission
Quality and Process Improvement:
Review and perform quality control (QC) on dossiers prepared by junior team members
Share best practices and ensure consistency in submission processes
Mentor and coach junior team members on SOPs, processes, and regulatory guidelines
Tools and Systems:
Proficient in MS Office (Excel, PowerPoint), Adobe Professional
Hands-on experience with Regulatory Information Management Systems (RIMS), preferably Veeva Vault or Trackwise
Experience with regulatory document management and publishing tools
Required Skills & Qualifications:
Education:
BPharm / MPharm / Pharm D / MSc
Experience:
4–6 years of experience in regulatory affairs, specifically in EU and ASEAN markets
Key Competencies:
Strong written and verbal communication skills
Deep knowledge of global regulatory submission formats
Attention to detail and excellent organizational skills
Ability to multitask and work in a dynamic environment
Flexibility to move across projects and deliverables
Nice to Have:
Exposure to diverse regulatory deliverables
Willingness to participate in training and development programs
Knowledge sharing and mentoring capabilities
Equal Opportunity Statement:
Indegene is an Equal Opportunity Employer and is committed to fostering an inclusive, diverse workplace.
We do not discriminate on the basis of:
Race, religion, sex, color, age, national origin, pregnancy, sexual orientation, gender identity, physical ability, veteran status, or any other legally protected characteristics.
All employment decisions are made based on business needs, merit, and qualifications.
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