What are the responsibilities and job description for the Associate Regulatory Affairs Director, Regulatory Science & Execution position at AstraZeneca GmbH?
Support strategies and implement regulatory activities for assigned product and regulatory jurisdictions, with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This individual will provide operational and strategic regulatory input to cross-functional teams responsible for driving programs in relevant regulatory jurisdictions. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.
Accountabilities
- Drive regulatory execution and implementation of regulatory strategies in the relevant regulatory jurisdiction, actively supporting relevant Regulatory Leads via the Regulatory Subteam (RSTs) to deliver on business objectives for assigned products / programs (e.g. clinical trial applications, marketing authorization applications, orphan drug designation applications, paediatric submissions, etc.).
- Contribute to the planning and conduct of regulatory authority meetings in relevant jurisdictions, providing input to submission strategy and other critical regulatory documents. May represent Alexion as point contact with relevant Health Authorities and / or lead interactions with such authorities or other relevant external collaborators.
- Lead all aspects of operational activities and execution related to the Regulatory management in the relevant jurisdiction, in support of the Regulatory Lead, coordinating teams working on such deliverables.
- Support Regulatory Lead and contribute actively to internal Governance and advisory bodies, or other relevant internal activities, including on the development and management of select Regulatory processes and procedures, as well as inspection / audit support.
- Collaborate with Senior Management and Enterprise functions (e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide regional regulatory insight and broader drug development expertise.
- Keep up to date on the latest regulatory requirements and trends, and contribute to the shaping of the regulatory science environment!
Essential Skills / Experience
Desirable Skills / Experience
Ready to make an impact? Apply now!
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