Head of Regulatory Strategy

3 weeks ago

London, Greater London, United Kingdom Novartis Farmacéutica Full time

Job Overview

At Novartis Farmacéutica, we are dedicated to transforming healthcare and enhancing the lives of patients globally. Our Development Team is on a mission to innovate and streamline our processes, ensuring that we deliver our medicines to those in need as swiftly as possible. We are looking for exceptional talent to join our team and contribute to this vital work.

Position Summary

The role of Head of Regulatory Strategy and Intelligence involves a hybrid working model, requiring presence in our London office for part of the week. In this pivotal position, you will guide the application of regional regulatory standards and insights, providing strategic direction and advocacy for our products throughout global development. Your efforts will be crucial in achieving Regulatory Affairs objectives and ensuring compliance with regulatory frameworks.

Key Responsibilities

Primary Duties:

  1. Deliver regular updates and briefings to Global and Regional Policy Leaders regarding significant global regulatory matters, actively participating in internal product team discussions to integrate regulatory policy considerations into business strategies.
  2. Offer strategic regulatory counsel to Regulatory Affairs colleagues on drug development initiatives and product registrations, preparing for health authority engagements while assessing the implications of emerging regulatory policies on Novartis projects.
  3. Gather and coordinate feedback from internal stakeholders on proposed legislation, regulations, and guidelines; advocate for Novartis' interests within trade associations.
  4. Act as a representative in external bodies such as trade associations, consortia, and Public-Private Partnerships.
  5. Identify and escalate critical information to stakeholders, collaborating with Corporate Affairs to influence legislative proposals.
  6. Lead the internal cross-functional implementation of regulatory guidelines in new and evolving areas.
Candidate Profile

Qualifications:

  1. A Bachelor's or Master's Degree in a relevant field such as science, health policy, or law.
  2. Proven experience in regulatory affairs or drug/biologics development.
  3. Demonstrated success in a regulatory or health policy role, with a comprehensive understanding of the regulatory landscape.
  4. Exceptional interpersonal, communication, and negotiation abilities, with a talent for fostering strategic thinking within teams.
  5. Experience working in a complex, cross-functional environment, whether in industry or health authority settings.
  6. Fluency in English is required.
Why Join Us?

At Novartis, we believe that addressing the needs of patients and their families requires more than just scientific innovation. It necessitates a collaborative community of passionate individuals who support and inspire one another. Together, we strive to achieve breakthroughs that significantly impact patients' lives.

Commitment to Diversity & Inclusion: Novartis is dedicated to fostering an inclusive workplace and building diverse teams that reflect the patients and communities we serve.

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