AstraZeneca Jobs Vacancies 2023 Apply Online AstraZeneca Job Career Portal @ astrazeneca.com

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Are you a Leader with expertise in, and passion for science working in Regulatory Affairs field? If so, AstraZeneca might be the one for you!

ABOUT ASTRAZENECA

AstraZeneca is a global, innovation-driven Biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.

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. Always committed to lifelong learning, growth and development.

ABOUT OUR REGULATORY AFFAIRS TEAM

Across our diverse group of markets, we bring transformative products to the market, to ultimately transform the lives of people living with serious diseases. Leaders in the market, we utilize our large data sets and scientific backing, to influence opinion leaders and key stakeholders. Adapting and transforming each unique healthcare system in our markets.

Our AfriCAN Cluster Regulatory Affairs team is successful and committed to everyday excellence. We have enjoyed a number of successes thus far in 2023 – having achieved a number of approvals on new products and new indications to date. We put the patient first in every decision we make. Compliance is at the heart of all we do. Collaboration within the team, the wider cross functional team and industry bodies is key to our success.

What you’ll do?

As the successful candidate, you will provide strategic and operational regulatory leadership to the development, commercialization and life cycle management of the assigned product(s) in product teams. Apply knowledge of current local and global Regulatory trends to identify future regulatory requirements and strategies. Influences Regulatory authorities through regular contacts to improve Regulatory outcomes. You will also be responsible for the management of a skill group such as CMC, Regulatory Affairs project management, etc. Drive skill development, performance management and resource allocation.

Typical accountabilities will include:

• Provides effective lobbying and influencing on regulatory agencies and trade associations on product and legislative development issues and monitors changes in the regulatory environment in nominated region to support and advise relevant functions.
• Provides strategic regulatory advice support for product developments regional therapy area.
• Represents AZRA on relevant external Trade Association committees to ensure AZRA and/or AZ views on key issues are known.
• Ensures adequate risk assessments and mitigation plans are included in the regulatory strategy documents.
• Contribute effectively to Global Development programmes, providing expert advice and interpretive inputs on market legislation and requirements that impact on new and existing product registrations.
• Ensures effective collaboration across the global, regional and local Regulatory Affairs interface enabling rapid and effective submissions, approvals and other product maintenance activities.
• Participates in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project
• Ensures all markets remain in compliance with product licenses maintained and ensuring improvement plans are in place to close compliance gaps. Provide support and advice on training and development to ensure all regulatory personnel in markets have an appropriate knowledge of quality and compliance
• Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration.

If this sounds appealing, please read on to understand the experience and skills we’re looking for…

ESSENTIAL SKILLS & EXPERIENCE REQUIRED?

Essential

• Bachelor’s Degree in Pharmacy. Advanced degree a plus.
• Significant experience of regulatory drug development, manufacture, commercialization or equivalent.
• Proven successful leadership and project management experience.
• Broad background of experience of working in several groups in regulatory affairs or experience at a health authority.
• Knowledge of regulatory procedures and legislation for drug development, product registration, line extension and license maintenance.

Desirable

• Significant Regulatory Experience across global projects and regions.
• Strong commercial awareness.
• Problem solving skills.
• Focus on delivery and results.
• Excellent strategic influencing and negotiation.
• Develops collaborative working relationships.

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.

Join the fastest growing pharmaceutical in our markets, set up to fuel further growth. Be part of our shared ambition and pride: our strong heritage, our turnaround story, and early investment and commitment in International markets. There’s no better place to feel inspired and energized.

SO, WHAT’S NEXT?

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

Click the link to apply no later than and we’ll be in touch as soon as we can.

WHERE CAN I FIND OUT MORE?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

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