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!