Regulatory Affairs Associate III

Watson Pharama

5 - 7 years

7 - 9 Lacs

mumbai

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Skills Required

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Work Mode

Work from Office

Job Type

Full Time

Job Description

The opportunity

Responsible for leading and managing applications through the regulatory approval process, including preparation of Post Approval Submissions to Health Canada (HC), to obtain timely approvals. Work independently as a professional and keeps management informed of significant regulatory issues that affect assigned products/projects.

How you ll spend your day

Prepare, compile, review and submit high quality submissions for all post approval activities in accordance with Health Canada Regulations and corporate standards.
Support the development and implementation of regulatory strategies for defined projects until approval and launch as applicable.
Interface with R&D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner
Responsible for evaluating change controls for regulatory filing assessments in accordance with HC guidance documents. Subsequently prepare and ensure all timely post approval regulatory activities, as applicable.
Keep current with the Teva work procedures, Health Canada Regulations/ Guidance as well as ICH regulations
Business development assessments as applicable
Other projects and duties as required/assigned

Your experience and qualifications

M. Pharma degree in a scientific discipline
Minimum 5-7 years in Regulatory affairs in post approval (EU/FDA with preference for HC) and overall pharma experience of 7-10 years
Preferred, experience with sterile products.
Excellent oral and written communication
Excellent organizational skills and the ability to multi-task; detail oriented.
Possesses strong critical and logical thinking

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