CMC Regulatory Affairs Manager - Submission Excellence and Project Management Macclesfield, England
Job description
Are you passionate about the application of science to deliver life changing medicines?
About AstraZeneca
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
Chemistry, Manufacturing, and Controls (CMC)
Our Chemistry, Manufacturing, and Controls (CMC) Regulatory function spans across the product lifecycle and is responsible for the regulatory strategy relating to the development, manufacture and testing of all of our medicines.
With our expertise we interpret, anticipate and shape global Health Authority expectations to build insightful CMC and Device Regulatory Strategies.
We are the bridge between our R&D functions, Operations sites, Quality and Global Supply Teams in helping safe, effective medicines reach the right patient at the right times. We manage the timely preparation and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout the commercial lifecycle; including Clinical Trial Applications (CTAs), Marketing Authoring Applications (MAAs) and all post approval activities improving the value of business critical Supply Chain changes to the AZ organization by supplying the regulatory context, intelligence and guidance required to advise the development of robust plans for change initiatives.
What you’ll do
We are looking for a Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs Manager to join us in one of our following sites: Macclesfield (UK), Sodertalje (SE) or Gothenburg (SE) with the flexibility to work remotely for up to 2 days a week.
Being a CMC RA Manager, means that you will effectively manage the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges to deliver the needs of both the AZ business and the customer. You will project manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product lifecycle.
As a CMC RA Manager you will also contribute and own the regulatory CMC components of business-related projects having effective levels of interactive communication with collaborators and project team members to ensure that relevant timelines and regulatory commitments are appropriately communicated. The accountabilities also include responsibility for change management as assigned and to ensure the learning from own projects are shared with other co-workers/within the function.
Responsibilities:
Manage/Lead assigned projects; define and agree regulatory submission strategy, complete data assessment to ensure the authored regulatory CMC contributions are in line with AstraZeneca and Health Authority requirements throughout the product lifecycle
Leverage regulatory intelligence to optimize submission content, employing quality risk management as appropriate
Maintain regulatory databases related to submissions
Capture and communicate Health Authority approval status
Continually evolve and develop the organisation’s regulatory expertise; through proactive recording and communication of regulatory insights gained via Health Authority interactions
Build and maintain good relationships with internal and external stakeholders to facilitate regulatory execution and delivery
Contribute to business process optimization activities, removing waste and maximising efficiency
Apply GxP principles according to the stage of product lifecycle
Education, Qualifications, Skills and Experience
Essential for the role:
Bachelor’s degree in a scientific subject area or equivalent
Experience in a biopharmaceutical (or related) manufacturing, technical or regulatory environment
Awareness of CMC considerations and how they apply in a regulatory environment
Project management expertise with the ability to adapt to changing situations to ensure on time delivery
Effective communication (written and oral) and stakeholder management skills
IT Skills
Desirable for the role:
Understanding of current regulatory CMC requirements and the CMC contributions to clinical and/or commercial regulatory dossiers
Knowledge of the drug development process and commercial lifecycle of a pharmaceutical product
Direct/indirect Regulatory Affairs CMC experience with submissions for synthetics and/or biologic and biotechnology derived products such as monoclonal antibodies or sophisticated biologic products e.g. vaccines or ATMPs
Understanding of regulations and guidance governing the manufacture of biotechnology products
Demonstrated research skills in understanding, interpreting and applying regulations or guidance from external sources; including industry bodies and national competent authorities
Lean capabilities
Understanding and application of appropriate risk management
Proactive in identifying and acting on opportunities to drive operational improvements
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!
Competitive salary and benefits package on offer.
The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save plans, A performance recognition scheme and a competitive, generous remuneration package.
Where can I find out more?
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