Senior Associate - CMC5

Primary Responsibilities:

• 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 to 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 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