Senior Associate Job at ClinChoice | Pharma Graduates Apply Now
A leading global pharmaceutical organization is hiring for the position of Senior Associate – CMC5 in Bengaluru, India. The Senior Associate Job involves regulatory submissions, CMC documentation, lifecycle management, and compliance activities, primarily focusing on EU and CIS regions. Candidates with a background in Chemistry, Pharmacy, or related scientific fields and hands-on experience in CMC regulatory affairs are invited to apply.
- Job Title: Senior Associate – CMC5
- Location: Bengaluru, India
About The Company
At ClinChoice, we are dedicated to bringing high-quality and innovative healthcare solutions to the global market. Our team of experts collaborates across various functions to ensure that we meet the regulatory standards and deliver exceptional products worldwide.
Primary Responsibilities of the Senior Associate Job
- Manage the preparation and submission of new product registrations, post approval submission, and follow-up closely on queries and through approval.
- 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 application, 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 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 for the Pharmacy Job
- Minimum Pharmacy or related scientific field.
- For this Pharmacy Job, experience in CMC regulatory affairs for pharmaceutical products is required.
- 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.
