Associate Jobs at ClinChoice | Chemistry Candidates Apply Now
Are you looking for Associate Jobs in regulatory affairs that align with your chemistry background and global exposure? ClinChoice Careers is hiring a Senior Associate – CMC5 in Bengaluru, India. This opportunity is ideal for candidates seeking BSc Chemistry Jobs with hands-on experience in CMC regulatory filings, EU and CIS submissions, and end-to-end product lifecycle management in the pharmaceutical industry.
About ClinChoice
ClinChoice is a global full-service CRO and regulatory consulting organization supporting pharmaceutical, biotechnology, and medical device companies worldwide. Through ClinChoice Careers, professionals gain access to international regulatory exposure, structured career development, and opportunities across CMC, regulatory affairs, clinical research, and quality. ClinChoice is known for its strong compliance culture, scientific excellence, and commitment to delivering high-quality regulatory solutions.
- Position: Senior Associate – CMC5
- Location: Bengaluru, India
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 the 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 products and line extensions for new product launches, tender applications, and other needs as required.
- 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 the 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.
Qualifications and Desired Skills:
- Minimum B.S. 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 multitask 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.
