Global Regulatory Affairs Manager

6 days ago

Bengaluru, Karnataka, India Lifelancer Full time

Job Title: Global Regulatory Affairs Manager

About the Role:

We are seeking an experienced and skilled Global Regulatory Affairs Manager to join our team at Lifelancer. In this role, you will be responsible for managing multiple projects and teams simultaneously, providing assessments and conclusions within and across departments.

Your Key Responsibilities:

  • Manage multiple projects and teams, ensuring timely delivery of regulatory submissions and reports.
  • Develop and maintain a holistic view of the global regulatory integrated plan at the asset level, collaborating with the GRL and RMT to ensure alignment with the Global Regulatory Strategy.
  • Drive the execution of agreed plans to ensure team deliverance per the Global Regulatory Strategy, performing scenario planning, impact analyses, critical path analyses, and facilitating risk mitigation.
  • Leverage expertise to assist RMTs and GRLs with submission delivery strategies that align with R&D objectives, e.g., Hyper-Acceleration, Acceleration in regions.
  • Implement a structured approach with assigned RMTs to ensure that the submission delivery strategy is aligned with the Global Submission Strategy throughout the late-stage Development lifecycle.
  • Proactively partner as a Single Point of Contact with RMT, Submission Coordination, and Publishing colleagues to identify and remove barriers that prevent successful outcomes on defined filing strategies.
  • Drive RMT Meetings and other Cross-Functional, Regulatory-Owned Engagements for success, ensuring logistics, agenda topics, and meeting materials are available and organized for the team.
  • Proactively identify upcoming activities or milestones that might impact regulatory deliverables and escalate issues and blockers to the Director, Regulatory Asset Oversight, and leadership.
  • Promote and drive the use of integrated Regulatory technologies to provide real-time, accurate submission status information (visuals and reports) for RMTs to highlight compliance from central dispatches through to registrations across markets.
  • Maintain meaningful metrics and KPIs to assess individual and team performance, aligned across the Regulatory Asset Oversight function.

What We Offer:

  • A competitive salary range of $120,000 - $180,000 per annum, depending on experience.
  • A comprehensive benefits package, including health insurance, retirement plan, and paid time off.
  • Ongoing training and development opportunities to enhance your skills and knowledge.
  • A collaborative and dynamic work environment, with a team of experienced professionals.
  • The opportunity to work on high-profile projects and contribute to the success of our clients.

About Us:

Lifelancer is a talent-hiring platform connecting professionals with opportunities in Life Sciences, Pharma, and IT. We strive to unite science, technology, and talent to get ahead of disease together.

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