Job Title: Senior Associate – CMC5
Location: Bengaluru, India
Department: Regulatory Affairs – CMC
Employment Type: Full-Time
Role Overview:
We are seeking a Senior Associate – CMC5 to manage regulatory submissions and lifecycle activities for pharmaceutical products. This role involves preparing, reviewing, and submitting CMC modules (2 & 3) for new product registrations, supporting post-approval submissions, and ensuring compliance with regional and global regulatory requirements. The ideal candidate will have exposure to EU and CIS regulatory filings and be adept at coordinating cross-functional teams for efficient regulatory execution.
Key Responsibilities:
Prepare and submit new product registrations and manage post-approval submissions, including tracking queries and approvals.
Write and review CMC modules 2 & 3, ensuring accuracy and regulatory compliance.
Support product lifecycle management activities and maintain documentation for transparency and efficiency.
Ensure compliance with local and regional regulatory requirements and foster relationships with health authorities.
Provide regulatory support for new product launches, line extensions, tender applications, and other business needs.
Maintain regulatory tracking tools and work processes to improve performance and reporting.
Contribute to regulatory intelligence initiatives at local and regional levels.
Develop regulatory strategies, prepare applications, and support maintenance activities within the assigned therapeutic area.
Execute regulatory strategies aligned with the business plan and ensure adherence to timelines and quality standards.
Review formulation data, ingredient lists, claims, and labeling components according to SOPs and regulatory guidelines.
Qualifications & Experience:
Minimum B.S. in Chemistry, Pharmacy, or a related scientific field.
Proven experience in CMC regulatory affairs for pharmaceutical products.
Hands-on experience with Module 3, Module 2.3, and relevant Module 1 eCTD documentation.
Familiarity with EU pharmaceutical guidelines and their interpretation.
Strong project management skills and ability to multi-task effectively.
Excellent attention to detail, written and verbal communication skills.
Ability to work independently, including in remote settings.
Why Join:
This position offers the opportunity to lead regulatory CMC activities, contribute to global product submissions, and ensure compliance across multiple regions. You will work in a dynamic, cross-functional environment, supporting strategic product registrations and lifecycle management.
Equal Opportunity Statement:
We are an equal opportunity employer committed to diversity and inclusion. All qualified applicants will be considered regardless of race, gender, religion, sexual orientation, disability, or veteran status.
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