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.

Date Posted

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.