The Senior Regulatory Affairs Specialist, International Regulatory Affairs will be responsible for executing regulatory activities for assigned products across the International region, 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 work collaboratively with regulatory and cross-functional product / project teams, including Alexion affiliates and Astra Zeneca marketing companies, to execute deliverables that support the geographic expansion of the portfolio as well as maintenance of regulatory authorizations. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.
Accountabilities :
Actively support International Regulatory Leads (IRLs) to deliver on business objectives for assigned products / programs by coordinating and preparing deliverables for regulatory submissions (e.g., clinical trial applications, marketing authorizations, orphan drug designations, renewals, pediatric submissions) in assigned jurisdictions in close collaboration with local regulatory affairs and cross-functional colleagues (e.g., medical affairs, commercial, clinical development, CMC).
Support the planning and conduct of regulatory authority interactions in relevant jurisdictions, providing execution support to the International Regulatory Leads and other key stakeholders (e.g., Country Regulatory Affairs).
Manage operational activities related to regulatory authorizations according to current regulatory internal and external requirements for the International region.
Support the development and management of select Regulatory processes and procedures, as well as inspection / audit support.
Stay up to date on the latest regulatory requirements and trends and share information on these as requested by the business.
Ensure exemplary behavior, leadership, ethics, and transparency within the Enterprise, with Health Authorities and other external stakeholders.
Essential Skills / Experience :
2+ years of relevant experience in the pharmaceutical industry, prior Regulatory experience required
Knowledge of drug development by background and experience
Experience executing several regulatory activities, which might include clinical trial applications, orphan designation applications, pediatric applications, marketing authorization applications in at least one regulatory jurisdiction (experience in the International markets strongly desired)
Ability to manage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion
Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization
Strong interpersonal, and written / verbal communication skills
Understanding of Gx Ps in relevant areas and solid understanding of where to seek and how to interpret regulatory information
Education :
Bachelor’s Degree, life science highly desirable
Postgraduate degrees relevant to the role (e.g., MSc, Ph D) is a plus
Additional certification and / or training relevant to the role
Competences :
Excellent use of Microsoft 365 (Office) tools, ideally well skilled on the use of Power Point
Experience working in regulatory documentation system (like Veeva) is a plus
Proficient in English in the Corporate setting. Additional languages are a plus

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