Team Lead

4 weeks ago

Gurgaon Gurugram India Michael Page Full time
  • Work with a leading pharmaceutical giant
  • Excellent work culture that offers multiple growth opportunities
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 (i.e., Europe, NAMRegion)
  • Qualification or certification in IT advantageous
What's on Offer
  • Potential growth opportunities
  • Employee friendly culture
  • Tremendous learning opportunity

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