Senior Associate – Regulatory Affairs (CMC)

About this role

Responsibilities:

• Manage the preparation and submission of new product registrations, post approval submission, and follow-up closely on queries and through approval

• Responsible for reviewing and writing CMC modules 2 and 3

• Exposure to EU and CIS region in regulatory filings

• Herbal product development background

• 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 and tender applications when necessary

• Maintain regulatory work processes and tracking tools that improve performance levels and transparency

• Exposure in writing of Product Quality Review

• Promote regulatory intelligence in both local and regional initiatives

• Develop regulatory strategies, prepare regulatory applications, and support maintenance activities within relevant therapy areas

• Execution of regulatory strategies (local and regional) that are 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 per set standards

• Compilation and review of labeling components per SOP

Deliverables:

• CMC modules 2 and 3

• Management of the preparation and submission of new product registrations, post approval submissions, and follow-up on queries through approval

• Review of CMC modules

• Execution of regulatory strategies (local and regional) that are in line with the business plan

• Compilation of PQR as per SOP – Summary report of variations submitted as per the specified period.

• Review of formulation, generation of ingredient list, and claims per set standards

• Compilation and review of labeling components per SOP

Experience/Qualifications:

• Bachelor’s/Master’s degree in Life Science/Pharma

• Four to six years of relevant work experience

• RAPS certification is desirable