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CMC Regulatory Affairs Associate Director and Team Manager

Location Macclesfield, England, United Kingdom Cambridge, England, United Kingdom Job ID R-120784 Date posted 01/10/2021

Do you have expertise in, and passion for CMC Regulatory? Would you like to apply your expertise to impact delivery of medicines that patients need in a company that follows the science and turns ideas into life-changing medicines? Then AstraZeneca might be the one for you!

At AstraZeneca work with diverse minds, all united by a shared passion to learn, grow and discover.

Operations Regulatory is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across AstraZeneca’s global supply chain. We're very proud to enable accelerated and secure delivery of medicines to our patients.

We are now looking for an CMC Regulatory Affairs Associate Director and Team Manager to support and lead a team of approximately 5-10 CMC specialists. The team is responsible for managing post-approval CMC maintenance activities/projects. The line manager also strategically supports the project portfolio for which the team is accountable.

The highly collaborative team of CMC specialists are dedicated to delivering high-quality CMC Regulatory submissions in a timely manner. As a team, the group are advanced problem-solvers who collaborate with very positive energy and also enjoy each others' company with the occasional lunch and different activities. The Lean concept is part of the teams’ culture and all team members understand that the job consists of two parts; enable the end-to-end supply chain and AstraZeneca’s license to operate and ensure processes and standards are continuously improved and waste removed.

You will report to CMC Regulatory Affairs Director and Group Manager and play a key role in the leadership team. The position is a permanent position and based in either Macclesfield (preferred) or Cambridge, UK.

What you'll do:

As our CMC Regulatory Affairs Associate Director and Team Manager, you will provide operational, tactical and strategic CMC regulatory expertise and direction to product and project teams in support of products throughout the product lifecycle.

You will be representing Operations Regulatory in global cross-functional teams such as the Global Supply Teams (GST). You will also be expected to work closely with other regulatory functions in AZ, as well as the manufacturing sites.

  • Line -management and development of a team of professional regulatory staff
  • Strategically plan CMC submissions and provide AZ technical functions clear concise guidance on current regulatory requirements.
  • Ensure expert recommendations and decisions relating to CMC for individual products/product portfolios including risk management and mitigation

Essential requirements:

  • Degree, or equivalent, in Chemistry, Pharmacy, Chemical Engineering or other relevant science related field
  • Excellent written and verbal English
  • Previous experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs

Skills and capabilities / The leader we're looking for:

We're looking for you who either is an experienced leader or has extensive knowledge in Regulatory CMC. Preferably a mix of both, but essentially you need to feel very comfortable taking lead in one area to enable space to grow in the other. No matter where your strength lies you need a can do-attitude, seeing opportunity rather than obstacles and possess great interpersonal skills. To be passionate about the team’s development is absolutely critical, both on a broader strategic level and for each team members own development. You have excellent communication skills and the ability to make effective decisions despite uncertainty and/or incomplete information to drive business outcomes.

It's a big plus if you have experience or interest in the LEAN concept and understand how this can be adapted to an office-based environment.

Why AstraZeneca? Our offer to you:

When we at AstraZeneca see the chance to change, we take this opportunity - every opportunity, no matter how small, can be the beginning of something big. Delivering medicine that changes people's lives is about having an entrepreneurial spirit - finding moments and understanding its potential.

We are looking for you, who together with your team will make a difference for patients' lives every day. This through your ability to independently lead and motivate your team to achieve set goals within budget, time and to the right quality. AstraZeneca welcomes your positive attitude and your desire to develop both yourself, your team and the department. You will get use for your drive and your ability to work diligently and structured even at a high tempo.

Location: Macclesfield (preferred) or Cambridge UK

Salary: Competitive + Excellent Benefits

Welcome with your application no later than 22nd October 2021 – apply now!

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn

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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

50056704 E RGPD R&D Oncology (Susan Galbraith (07016555)) (85008610)

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.