My client is a global pharmaceutical company who specialise in vaccines. It is an exciting time for the company as they are seeking individuals who are willing to research, develop and manufacture pharmaceutical medicines. They are currently seeking a Senior Manager, Global Regulatory Affairs based in Texas to join their dynamic team! This is a full time permanent hybrid position.
As a Senior Manager, Global Regulatory Affairs, you will be responsible for regulatory submissions, interactions, and strategy related to products within the US.
Responsibilities
- Ensure cross portfolio aligned regulatory strategy to assure timely approvals for all US submissions.
- Facilitate integration of US-based individuals within portfolio group and integration of US-specific regulatory aspects into projects in general within the portfolio.
- Managerial responsibilities for US-based individuals within a specific Global Regulatory Affairs (GRA) project/portfolio, advice for US specific activities/processes, ensure appropriate training of US-based staff, and issue escalation.
- Ensure quality and process improvement within US and provide cross portfolio resources support as appropriate.
- Provide advice on US-specific activities and ways of working, processes as mentor or coach; in this role, provide support, as needed, for meetings/teleconferences with US regulatory agency.
- Ensure the training of US-based personnel, and ensure completeness of training curriculum, in compliance with Corporate Integrity Agreement (CIA).
- Ensure that regional strategic input is provided into Regulatory Affairs project strategy and escalation as appropriate.
Qualifications
- Bachelor’s Degree in Pharmacy, Chemistry, Biology, Medicine, or similar discipline.
- More than 8 years of experience in regulatory affairs, with specific experience with US regulatory environment
- 8+ years’ Experience in managing teams and leading in a matrix organization
- Experience at a large global pharmaceutical or vaccines company
- Experience leading global teams
- A good understanding of drug development processes and strategies, with proven ability to apply innovative statistical thinking to meet project and/or business objectives
- PhD degree in a quantitative discipline such as epidemiology, health economics, health services research, health informatics, or biostatistics
- Prior experience working in oncology within the pharmaceutical/biotech industry (preferably in real-world evidence, epidemiology, or health outcomes functional areas)
- 5+ years of experience working with RWD for use in pharmacoepidemiology research with good practical knowledge in biostatistics applied to clinical/epidemiological research
- Excellent problem-solving and analytical skills and enjoy finding efficient and innovative solutions to challenging problems
- Self-reliant with the ability to deliver robust, timely, high-quality analytics
- Fluent in written and spoken English with the ability to effectively communicate and able to articulate complex concepts to diverse audiences, demonstrated throughout the interview process
Connect
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything