Senior Associate Job – Chemistry & Regulatory Affairs in India
Are you looking for an exciting Chemistry Job in India with a focus on Regulatory Affairs? Join us as a Senior Associate – CMC5 and become part of a dynamic pharmaceutical team in Bengaluru. This Senior Associate Job involves managing regulatory submissions, preparing CMC modules, and ensuring product compliance. It’s a great opportunity for professionals seeking growth in Regulatory Affairs Jobs and Chemistry Careers within the global pharmaceutical sector.
About the Institute
This company is a leading global pharmaceutical organization committed to scientific innovation and healthcare excellence. We offer career growth through challenging Regulatory Affairs Jobs, Senior Associate Jobs, and Chemistry Jobs in India. Join a collaborative environment that values innovation, quality, and compliance — and make a real impact in the pharmaceutical industry.
Job Details
- Job Title: Senior Associate – CMC5
- Location: Bengaluru, India
About the Role
The Senior Associate – CMC5 will play a key role in managing Regulatory Affairs activities for pharmaceutical products. This Chemistry Job focuses on preparing regulatory submissions, maintaining compliance, and supporting product lifecycle management. Ideal for candidates seeking a Senior Associate Job in Regulatory Affairs or Pharmaceutical Chemistry, this position provides exposure to
international markets like the EU and CIS regions.Qualifications and Desired Skills:
- Minimum B.S. in Chemistry, Pharmacy, or related scientific field.
- Experience in CMC regulatory affairs for pharmaceutical products.
- Experience in Module 3, Module 2.3, and relevant Module 1 e-CTD documentation.
- Ability to multi-task effectively and work independently in a remote setting.
- Attention to detail.
- Excellent written and verbal communication skills.
- Project management skills.
- Familiarity with EU pharmaceutical guidelines and their interpretation
Primary Responsibilities:
- Manage the preparation and submission of new product registrations, post approval submissions, and follow-up closely on queries and approvals.
- Responsible for writing CMC modules – 2 & 3.
- Exposure to EU & CIS region in Regulatory filings.
- Manage and coordinate product life cycle management.
- Ensure regulatory compliance with local regulatory requirements.
- Foster and maintain professional relationships with the health authorities.
- Provide regulatory support including timely registration of new product and line extensions to support new product launches, tender applications, and whenever necessary.
- Maintain regulatory work processes and tracking tools that improve performance levels and transparency.
- Promote regulatory intelligence in both local and regional initiatives.
- Development of regulatory strategies, preparation of regulatory applications, and support maintenance activities within relevant therapy area.
- Responsible for reviewing CMC modules.
- Execution of regulatory strategies (local and regional) in line with the business plan.
- Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met.
- Ensure adherence to timelines and quality set parameters.
- Review of Formulation, generation of ingredient list, and Claims as per set standards.
- Compilation and review of labeling components as per SOP.
Why Join?
This Senior Associate Job combines scientific knowledge with regulatory strategy, offering a unique opportunity to contribute to global Pharmaceutical Regulatory Affairs. It’s a perfect fit for professionals pursuing a long-term Chemistry Job in India with international exposure and advancement in compliance-driven pharmaceutical work.
