Senior International Regulatory Affairs Specialist

This is what you will do:

The Senior Regulatory Affairs Specialist, International Regulatory Affairs will be responsible for executing regulatory activities for assigned product 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 AstraZeneca marking companies to execute deliverables that support the geographic expansion of the portfolio as well as maintenance of regulatory authorisations. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.

You will be responsible for:

• Actively supporting 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 authorisations, orphan drug designations, renewals, paediatric submission) in assigned jurisdiction in close collaboration with local regulatory affairs and cross-functional colleagues (e.g. medical affairs, commercial, clinical development, CMC).

• Supports 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).

• Responsible to manage operational activities related to regulatory authorisations according to current regulatory internal and external requirements for the International region.

• Supports on the development and management of select Regulatory processes and procedures, as well as inspection/audit support.

• Actively be up to date on latest regulatory requirements and trends and share information on these as requested by the business.

• Ensure exemplary behavior, leadership, ethics and transparency within the Enteprise, with Health Authorities and other external stakeholders.

You will need to have:

Qualifications

• 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 GxPs 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, PhD) is a plus
• Additional certification and/or training relevant to the role over

Competences

• Excellent use of Microsoft 365 (Office) tools, ideally well skilled on the use of PowerPoint
• Experience working in regulatory documentation system (like Veeva) is a plus.
• Proficient in English in the Corporate setting. Additional languages are a plus

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 authorization and employment eligibility verification requirements.