Senior Strategist - Regulatory Affairs (CMC)

Key skills

• Software Engineering
• Problem Solving
• System Design

Job description

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 R

eview 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

Six to eight years of relevant work experience

RAPS certification is desirable

Apply on the official Clinchoice careers page

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