enior Associate – CMC5 (Chemistry, Manufacturing & Controls)
Location: Bengaluru, Karnataka, India
Employment Type: Full-Time
Experience Required: 3–6 Years in CMC Regulatory Affairs
Educational Qualification: B.Sc. in Chemistry, Pharmacy, or related scientific field
Job Overview
We are seeking a Senior Associate – CMC5 to support regulatory submissions and lifecycle management of pharmaceutical products in the EU and CIS regions. The role focuses on preparing, reviewing, and submitting CMC modules (Modules 2 & 3), ensuring compliance with local and international regulatory requirements, and providing strategic regulatory support across product life cycles.
The ideal candidate will have hands-on experience in CMC documentation, eCTD submissions, and regulatory intelligence, along with strong project management and communication skills.
Key Responsibilities
Regulatory Submissions & CMC Documentation
Manage preparation and submission of new product registrations and post-approval submissions.
Prepare and review CMC modules 2 and 3, ensuring alignment with regulatory standards.
Support eCTD documentation (Module 1, 2.3, and relevant modules) for EU and CIS submissions.
Respond to regulatory queries and facilitate timely approvals.
Lifecycle Management & Compliance
Coordinate product lifecycle management activities, including line extensions, labeling updates, and tender applications.
Ensure regulatory compliance with local, regional, and EU pharmaceutical guidelines.
Compile and review labeling components as per SOP and regulatory requirements.
Strategic & Operational Support
Develop and execute regulatory strategies in line with business objectives.
Maintain tracking tools and work processes to enhance performance and transparency.
Foster professional relationships with health authorities and support regulatory intelligence initiatives.
Review formulation, ingredient lists, and claims to ensure compliance with standards.
Required Skills & Competencies
Minimum B.Sc. in Chemistry, Pharmacy, or related scientific field.
3–6 years of experience in CMC regulatory affairs for pharmaceutical products.
Proficiency in preparing and reviewing Module 2.3, Module 3, and relevant Module 1 eCTD documentation.
Familiarity with EU pharmaceutical guidelines, their interpretation, and submission processes.
Strong attention to detail, organizational skills, and ability to multi-task independently.
Excellent written and verbal communication skills.
Project management skills to coordinate multiple submissions and regulatory tasks efficiently.
Why Join
Lead and contribute to regulatory submissions and CMC activities for innovative pharmaceutical products.
Gain exposure to EU and CIS regulatory frameworks and strategic regulatory planning.
Work in a dynamic, collaborative environment supporting global regulatory initiatives.
Enhance your career in pharmaceutical regulatory affairs and CMC documentation.
Apply now to join as a Senior Associate – CMC5 and be part of a global regulatory team driving compliance, quality, and innovation.
Explore more pharmaceutical, regulatory, and CMC opportunities at
thepharmadaily.com
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