Regulatory Affairs Manager

3 weeks ago

Bengaluru, Karnataka, India Lifelancer Full time

Join a dynamic team as a Regulatory Affairs Manager - Global Asset Oversight Expert and contribute to the development of innovative medicines that improve patients' lives.

**About Us**

Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. Our mission is to connect talented professionals with exciting opportunities in these domains.

**Job Overview**

$120,000 - $150,000 per annum (dependent on experience)

We are seeking an experienced Regulatory Affairs Manager to join our global asset oversight team. In this role, you will be responsible for managing multiple projects simultaneously, providing assessments and conclusions across departments, and leading the creation, maintenance, and continuous improvement of regulatory processes, policies, and systems.

**Key Responsibilities**

  • In close collaboration with the GRL and RMT, develop and maintain a holistic view of the global regulatory integrated plan at the asset level for operationalizing the Global Regulatory Strategy and supporting the GRL in ensuring appropriate resource is engaged to deliver to the plan.
  • Drive the execution of the agreed plans to ensure teams are on-track to deliver per the Global Regulatory Strategy (GRS), performing scenario planning, impact analyses, critical path analyses, and facilitate risk mitigation in response to any issues/risks that arise.
  • Leverage expertise to assist RMTs and GRLs with submission delivery strategies that align with R&D objectives, e.g., Hyper-Acceleration, Acceleration in regions.
  • Employing a structured approach with assigned RMTs to ensure that the submission delivery strategy is aligned with the Global Submission Strategy (GSS) throughout the late-stage Development lifecycle.
  • Proactively partner as a Single Point of Contact with RMTs and Submission Delivery Excellence colleagues to identify and remove barriers that will prevent a successful outcome on defined filing strategies.
  • Coordinate the RMT Meeting and other Cross-Functional, Regulatory-Owned Engagements for success, ensuring logistics, agenda topics, and meeting materials are available and organized for the use of the team.
  • Proactively identify upcoming activities or milestones which might impact regulatory deliverables and escalate issues and blockers to Sr. Manager, Regulatory Asset Oversight, and leadership as required.
  • Utilize 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. Contribute to Regulatory Asset Oversight function metrics and KPIs.
  • Leverage data from RIM systems to support RMT needs, ensuring it's accurate, complete, and fit for purpose.
  • Facilitate discussions with LOCs and RMTs as needed to ensure aligned submission delivery strategy and efficient lifecycle filing strategies from lead markets through to regional expansion.
  • May serve as SME inputting to Wows in conjunction with Stakeholders with a focus on continuous improvement, identification, and implementation of automation opportunities and compliance with Regulatory authority requirements.

**What We're Looking For**

We are seeking a highly motivated and experienced Regulatory Affairs Manager to join our team. The ideal candidate will have:

  • Bachelor's Degree
  • Extensive knowledge of drug development and manufacturing and supply processes.
  • Broad and deep knowledge of worldwide regulatory requirements.
  • Successfully managed multiple projects.

**Why Join Us?**

At Lifelancer, we offer a dynamic and supportive work environment, where you can grow your career and make a meaningful contribution to the development of innovative medicines.

**How to Apply**

Apply now through our website and take the first step towards an exciting career opportunity

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