CMC Regulatory Affairs Senior Director & Group Manager

Job title:

Company

AstraZeneca

Job description

Join our global team at AstraZeneca as a CMC Regulatory Affairs Senior Director & Group Manager. This role is an outstanding opportunity to lead a team of regulatory professionals, providing strategic technical CMC regulatory expertise and oversight across the product lifecycle. You will be responsible for delivering global CMC Regulatory strategy and leadership, ensuring positive regulatory outcomes that meet the needs of our business, markets, and patients.What You Will Do:As a CMC Regulatory Affairs Senior Director & Group Manager, you will lead and develop a team of 7-12 (Associate Director and Director level), ensuring the group has the regulatory and technical capabilities to progress the portfolio. You will be accountable for delivering the CMC Regulatory strategy for a complex portfolio of synthetic drug projects spanning Research & Development and Commercialisation. You will also ensure effective regulatory representation in partnership with technical experts at all health authority meetings and clear documentation of the discussion and agreements.Essential Skills/Experience:

Bachelors degree in Science, Regulatory Sciences or Pharmacy.
Previous experience in Regulatory/Drug development (Industry or Health Authority)
A significant knowledge and understanding of the science and technology associated with (bio)pharmaceutical development and manufacture.
Experience in Regulatory Affairs, with focus on CMC.
Has successfully contributed to at least one major regulatory submission in the global environment.
Significant project or line management experience in a relevant environment.
Ability to establish and foster excellent cross functional collaborations and communicate at multiple levels of the organization.

Desirable Skills/Experience:

PhD in Science, Regulatory Sciences or Pharmacy.
Experience of leading or contributing to significant change programs
Experience of Product Development, DPOM and associated resource requirements
Extensive in-depth knowledge of regulatory procedures and processes.

Why AstraZeneca?At AstraZeneca, we are more than one of the world’s leading pharmaceutical companies. We are a global, science-led, patient-focused biopharmaceutical company dedicated to discovering, developing, and commercialising prescription medicines for some of the world’s most serious diseases. We are committed to being a Great Place to Work where you are empowered to push the boundaries of science, challenge convention, and unleash your entrepreneurial spirit. Join us and be part of a high-performing team united by our shared purpose – to push the boundaries of science to deliver life-changing medicines.Next Steps:Ready to make a powerful difference? Apply now and join us in our mission to change lives with our innovative medicines!Location: Macclesfield UKSalary: Competitive + Excellent Benefits!Closing Date: 16th September 2024Where Can I Find Out More?Our Social Media,Follow AstraZeneca on LinkedInFollow AstraZeneca on FacebookFollow AstraZeneca on InstagramWhen we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.Date Posted 02-Sept-2024Closing Date 16-Sept-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.