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