Senior Regulatory Specialist

Alexion Pharmaceuticals; Madrid; Presencial; EUR 45.000 - 80.000; Jornada completa

Descripción de la vacante

Join a forward-thinking company as a Senior Regulatory Affairs Specialist, where you will play a crucial role in the registration and lifecycle management of innovative products that address the needs of patients with rare diseases. In this dynamic position, you will collaborate with cross-functional teams to ensure compliance with regulatory requirements while supporting the geographic expansion of the product portfolio. Your expertise in regulatory affairs will be instrumental in navigating complex issues and fostering relationships with regulatory authorities. If you are passionate about making a difference in the pharmaceutical industry, this opportunity is perfect for you.

Formación

• 2+ years of relevant experience in the pharmaceutical industry with prior regulatory experience.
• Knowledge of drug development and regulatory activities in international markets.

Responsabilidades

• Coordinate and prepare deliverables for regulatory submissions in assigned jurisdictions.
• Manage operational activities related to regulatory authorizations for the International region.

Conocimientos

Regulatory Affairs

Drug Development Knowledge

Project Management

Interpersonal Communication

Written/Verbal Communication

Educación

Bachelor’s Degree in Life Science

Postgraduate Degree (MSc, PhD)

Herramientas

Microsoft 365

Veeva

Descripción del empleo

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 AstraZeneca 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:

1. 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).
2. 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).
3. Manage operational activities related to regulatory authorizations according to current regulatory internal and external requirements for the International region.
4. Support the development and management of select Regulatory processes and procedures, as well as inspection/audit support.
5. Stay up to date on the latest regulatory requirements and trends and share information on these as requested by the business.
6. Ensure exemplary behavior, leadership, ethics, and transparency within the Enterprise, with Health Authorities and other external stakeholders.

Essential Skills / Experience:

1. 2+ years of relevant experience in the pharmaceutical industry, prior Regulatory experience required.
2. Knowledge of drug development by background and experience.
3. 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).
4. Ability to manage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion.
5. Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization.
6. Strong interpersonal, and written/verbal communication skills.
7. Understanding of GxPs in relevant areas and solid understanding of where to seek and how to interpret regulatory information.

Education:

1. Bachelor’s Degree, life science highly desirable.
2. Postgraduate degrees relevant to the role (e.g., MSc, PhD) is a plus.
3. Additional certification and/or training relevant to the role.

Competences:

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

Ready to make a difference? Apply now!

Date Posted: 04-feb-2025

Closing Date: 24-feb-2025