Regulatory Affairs Lead

At AstraZeneca, we are united by a common purpose: to push the boundaries of science to deliver life-changing medicines. Every day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide. Our purpose is results-oriented and so is our approach. Becoming a more agile and creative company means building a dynamic, inspiring culture where we celebrate diverse, bold thinking, are curious, creative, and open to new insights and ways of working.

Currently we are looking for Regulatory Affairs Lead to:

• deliver and maintain competitive licences and meet Regulatory Compliance requirements
• Lead the provision of high quality, comprehensive, technical and scientific expertise and information for internal and external customers on the AstraZeneca product range
• ensure GxP requirements are fully complied with and in line with the local GRP Quality Management System (QMS) SOP and all other AZ policies and Standards.

Job Responsibilities :

Lead the Organisation and Improve Productivity

• Provide effective leadership to Regulatory Affairs & the Medical Information Team to constantly deliver high quality outputs
• Work with Business Units and Medical Affairs Leadership Team to share expertise and identify/resolve issues
• Understand and promote MC Poland business needs into European strategies and decisions on drug development and regulatory filings/issues
• Lead the regular communication of best practice and facilitation of knowledge sharing
• Contribute to the AZ MC as a member of the Medical Affairs Leadership Team
• Create and maintain team environment that supports innovation, challenges the status quo and provides clear role accountability
• Responsible for the recruitment and retention of high calibre staff
• Responsible for the development, implementation and monitoring of individual development plans to build capabilities
• Accountable for managing the Regulatory Affairs & the Medical Information budget within agreed limits and according to phased targets
• Ensure departmental processes and organisation are continuously reviewed for creativity, efficiency and productivity
• Effective communication of functional reporting to the wider AZ MC Poland
• Through membership of the European Regulatory Management Team, influence the development of the European Regulatory function and effective, efficient processes
• Act as the external liaison representing AZ MC Poland in key contacts with professional bodies such as URPL, GIF, NIL and Infarma

Regulatory Intelligence & Policy:

• Proactively monitor and communicate changes and future trends related to issues which are likely to affect AZ interest.
• Ensure proactive participation at Industry association level to influence PL and EU legislation and procedures and interactions with Regulators
• Proactively influence key PL and European legislation in the business interest

Compliance and Governance

• Ensure timely submission of all licence variations and renewals and that licences are kept in compliance
• Ensure delivery of Medical Information activities in compliance with procedural documents, preparing local documentation where required to meet compliance/audit needs
• Lead cross functional MC Poland Team to ensure all major quality incidents/recalls are managed effectively with minimal/no impact on the business
• Act as a role model and ensure ethical/ professional behaviour
• Ensure that MC PL activities comply with AZ standards and HA requirements
• Responsible for ensuring all team members maintain up to date training records

Customer focus:

• Ensure appropriately skilled Regulatory Affairs & the Medical Information resource is provided to deliver commercial objectives
• Collaborate actively with Medical/Market  access & other line functions to provide the best-in-class product patient access outcome for the Polish market.
• Ensure, where appropriate, Regulatory Affairs input into the promotional approval process, to ensure that materials are in accordance with the current licence status and local regulations
• Provide strategic regulatory input to MC Poland in the business interest including input to strategic plan
• Ensure MC and R&D organisation are aware of impact of new legislation and procedures on product marketing and advertising (as appropriate)
• Build and maintains long-term, industry-leading relationships with the URPL, GIF and NIL

Requirements:

• Life sciences degree or appropriate professional qualifications
• Extensive regulatory experience in the pharmaceutical industry with a wide variety of registration projects and issues
• Clear and proven experience of people and performance management
• Track record of successfully negotiating with Regulatory Agencies
• Experience of operating at a strategic level in the business
• Working knowledge of the Healthcare system, EU and local legislation guidelines relevant to role.
• Strong personal integrity, customer and quality focus
• Excellent people and leadership skills
• Effective in dealing with ambiguous situations
• Effective in operating in an agile environment
• Must be able to adapt, organize, prioritize and work effectively in a constantly evolving environment and with multiple priorities
• Please note that excellent skills in Polish and English is a must!

Join AstraZeneca and help us deliver life-changing medicines. Be among our employees who continue to make us an innovation-driven company that stands firmly among the world’s leaders in biopharmaceuticals. APPLY!

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.