CMC Regulatory Affairs Manager- Submission Excellence & Project Management

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 Regulatory Affairs (CMC RA)

Our Chemistry, Manufacturing, and Control (CMC) Regulatory Affairs 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 craft 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 product lifecycle; including Clinical Trial Applications (CTAs), Marketing Authorisation Applications (MAAs) and all post approval activities improving the reliability and value of business critical Supply Chain changes to the AZ organization by supplying the regulatory context, intelligence and mentorship for robust approval and change management.

What you’ll do

We are looking for a Chemistry, Manufacturing and Controls Regulatory Affairs (CMC RA) Manager preferably with a Development or New Product Introduction (NPI) focus to join us in Gärtuna (Sweden), with the flexibility to work remotely for up to 2 days a week.

Being a CMC RA Manager for projects in the Development & NPI lifecycle states means that you will effectively manage the production of CMC documentation for designated product ranges to deliver against the needs of both the AZ business and the patients for internally and externally manufactured products. You will project manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards.

As a CMC RA Manager you will also contribute to and own the regulatory CMC components of business-related projects, applying 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 takeaways from own projects are shared with other co-workers/within the function.

Responsibilities:

• Manage/Lead assigned projects; define and agree regulatory submission strategy, coordinate cross-functional preparation of submission content and complete data assessments to ensure the authored regulatory CMC contributions are in line with AstraZeneca and Health Authority requirements throughout the development & NPI product lifecycle stages
• Leverage regulatory intelligence to optimise 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 partners to facilitate regulatory execution and delivery
• Contribute to business process optimization activities, removing waste and improving efficiency
• Apply GxP principles according to the stage of product lifecycle

Education, Qualifications, Skills and Experience

Crucial for the role:

• Bachelor’s degree or equivalent experience in a scientific subject area
• 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 plan, coordinate sophisticated programs of work and adapt to changing situations to ensure on time delivery
• Effective communication (written and oral) and partner leadership skills
• IT Skills

Desirable for the role:

• Detailed understanding of current regulatory CMC requirements and the CMC contributions to clinical and/or commercial regulatory dossiers
• Knowledge of the drug development and marketing application processes for pharmaceutical products
• Direct/indirect Regulatory Affairs CMC experience with clinical (IND & IMPD) or marketing application (NDA or BLA) submissions for synthetics and/or biologic and biotechnology derived products
• Understanding of regulations and guidance governing the manufacture of pharmaceutical 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.