Team Lead

2 months ago

gurugram, India Michael Page Full time
Work with a leading pharmaceutical giant Excellent work culture that offers multiple growth opportunities

About Our Client

Our client is one of the biggest pharmaceutical manufacturing organisation known for their high-end product portfolio across the globe. They play an instrumental role in shaping life of millions of people and contributing to the health care industry with their innovative technologies.

Job Description

Reporting into the "Head Regulatory", your responsibilities would include the following:

Develop and execute robust regulatory strategies, leveraging your expertise to navigate global regulatory agencies such as US-FDA, EMA, TGA, Health Canada, and more. Responsible for coordinating US regulatory submissions, including IND, sBLA product line extension applications, change control and labelling supplements. Ensure high quality submissions Executes and manages operational activities for assigned projects
Contributes to development of departmental goals and objectives Maintain compliance for assigned products (annual reports, DSURs, HA correspondence, monitor reference product label updates, adheres to SOPs Lead successful submissions and approvals for complex biologics/biosimilars, demonstrating your profound understanding of evolving regulatory landscapes. Collaborate closely with cross-functional teams including product development, quality operations, and supply chain to ensure seamless regulatory compliance. Drive life cycle sustainment plans, ensuring the continued success of products from launch to end-of-life (EOL). Build and mentor high-performing teams, fostering a culture of excellence and innovation.

The Successful Applicant

Bachelor's degree in Life Sciences or related scientific field 10 years of experience in Biologics, biopharmaceutical world Any experience in biosimilar is a plus, from which at least 5 years in managing teams Extensive experience in Regulatory Affairs In-depth knowledge of Regulatory Affairs in 1 or more geographies (, Europe, NAMRegion) Qualification or certification in IT advantageous

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