VP of Regulatory Chemistry, Manufacturing and Controls

Do you have expertise in regulatory affairs and quality, with the strategic vision to spearhead a team?

Would you like to apply your knowledge and experience to impact CMC in a company that follows the science and turns ideas into life changing medicines?

Then AstraZeneca might be the one for you!

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases.

But we’re more than one of the world’s leading pharmaceutical companies.

Working on a strong pipeline means so much more than producing innovative, ground-breaking medicines.

It allows us to be part of long-term development programs with the variety that comes from working at a pioneering science and technology organization.

We explore innovations and confront challenges that others won't, to have a greater impact on patients' lives.

We're proud of our pipeline – it’s not only changing the face of our industry for good and impacting the lives of patients, it’s redefining the careers of our people.

We’re committed to a culture of continuous learning and people development so everyone at AstraZeneca can grow and thrive.

Our Chemistry, Manufacturing, and Controls Regulatory functions span across the product lifecycle and are responsible for the regulatory strategy relating to the development, manufacture and testing of all of our medicines and vaccines.

As the VP CMC, you will lead the strategic direction and management of the CMC Regulatory Affairs function.

A large part of your responsibility is navigating approvals for the manufacturing science of AstraZeneca (AZ) innovative portfolio of drugs, vaccines, devices and digital therapeutics from early development through product divestment, or withdrawal with worldwide regulatory authorities; ensuring broad and rapid patient access.

Additionally, this role will provide CMC expertise and contribute to the delivery of the R&D and Operations strategies.

Provide strategic vision, leadership, management and oversight in defining a future-ready global CMC regulatory strategy to support and accelerate the AZ portfolio.

Responsible for all CMC regulatory activities for the AZ portfolio from late discovery through clinical development, market launch and product lifecycle management.

Develop and maintain effective working relationships across CMC technical functions, Global Quality Operations, Supply Chain & other regulatory groups; understand business plans and their implications for the function, and to instill a positive risk taking culture within the function.

Partner with Regulatory Affairs teams, marketing companies and regional regulatory affairs staff to influence developing views/guidance within leading Health Authorities on specific topics of relevance to their project or regulatory more generally.

This role can sit at our Gaithersburg, MD, Macclesfield UK, Gothenburg SWE, or Gartuna SWE location.

Minimum Qualifications:

PhD with a minimum of 10 years of shown relevant experience

Proven experience in the biotech or pharmaceutical industry, with focus on CMC Regulatory Affairs.

Experience at a senior level in Regulatory Affairs Quality.

Consistent track record in leadership roles including managing reports, teams and large groups globally.

Sound knowledge of and practical working experience with global requirements.

Extensive experience in working with regulatory agencies and demonstrated success in developing and implementing global regulatory strategies.

Experience working in a sophisticated and matrix environment is required.

Demonstrated experience in working with multiple partners.

Desired Qualifications:

Advance degree with 15 plus years of experience

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work.

Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit.

There’s no better place to make a difference to medicine, patients and society.

An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development.

We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next!

Are you already imagining yourself joining our team?

Good, because we can’t wait to hear from you.

Are you ready to bring new ideas and fresh thinking to the table?

Brilliant!

We have one seat available, and we hope it’s yours.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn

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Date Posted
03-Feb-2022 Closing Date
26-Jun-2022AstraZeneca 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 authorization and employment eligibility verification requirements.

Summary
Location: US
– Gaithersburg
– MD; Sweden
– Gärtuna; Sweden
– Gothenburg; UK
– Macclesfield
Type: Full time