Senior Associate, Regulatory Affairs

Job Description

About This Role

As a Senior Associate, Regulatory Affairs, you will support the Affiliate Regulatory Head in delivering operational support aligned with the strategic goals of the affiliate. Your primary focus will be on managing local operational regulatory activities to contribute to the late-stage pipeline and marketed products, working closely with relevant affiliate staff. Additionally, you will ensure compliance with comprehensive and up-to-date national regulatory guidelines and requirements, facilitating the successful execution of regulatory activities in the country.

What You'll Do

• Review and update Spanish translations of Product Information (PI), including SPC, PIL, and labels, ensuring compliance with local regulations and maintaining high-quality standards.
• Create PI versions for promotional materials and disseminate updates within the affiliate to ensure adherence to local procedures while maintaining an up-to-date local repository.
• Manage all aspects of artwork-related activities, including creation, review, approval, and handling deviations, ensuring alignment with regulatory requirements.
• Prepare, submit, and track regulatory submissions with National Competent Authorities (NCA) through the National Electronic Application System, addressing local requirements such as fragmentation of texts, educational materials, DHPCs, and national codes applications.
• Conduct operational regulatory activities to ensure compliance with local requirements while aligning with EU strategies and business priorities, adhering to established timelines.
• Maintain and oversee official and local regulatory databases, ensuring data accuracy and timely updates to support regulatory operations.
• Review and approve promotional and non-promotional materials, ensuring compliance with local regulations, company standards, and best practices, while monitoring key compliance metrics.
• Support the Affiliate Regulatory Head with audits, inspections, and the implementation of the Quality Management System (QMS), and manage regulatory procedures and policies within the affiliate.
• Collaborate with cross-functional teams, such as QA, PV, Marketing, and Medical Affairs, to provide regulatory operational support and ensure cohesive alignment across functions.
• Provide regulatory operational support to sub-cluster countries as needed, addressing unique regional requirements and ensuring consistent practices across borders.

Qualifications

Who You Are

You are an adaptable and resourceful professional with a passion for delivering results in a dynamic regulatory environment. Your experience in pharmaceutical regulatory affairs equips you to manage technical and strategic tasks, adapt to day-to-day changes, and take ownership of responsibilities. You thrive in innovative, collaborative settings and demonstrate flexibility, accountability, and a commitment to professional growth.

Required Skills

• Degree in Health Sciences (Pharmacy, Biology, or related fields) with a postgraduate specialization or master’s in Regulatory Affairs in the pharmaceutical industry.
• 1–2 years of experience in regulatory affairs within an innovative pharmaceutical company, or a combination of internship experience and relevant professional exposure.
• Fluency in Spanish, advanced English skills (C1 minimum), with Portuguese as a plus.
• Familiarity with tools such as RAEFAR, PLM, Veeva Insights, and National Regulatory Databases.
• Proven ability to review translations, manage regulatory submissions (e.g., dossiers), and oversee compliance with regulatory materials.
• Strong interpersonal skills to build trust and inspire confidence while working across all organizational levels.

Preferred Skills

• Ability to handle technical tasks such as auditing, maintaining databases, and preparing regulatory materials with accuracy.
• Understanding of decentralized licensing and the ability to navigate local, regional, and EU regulatory environments.
• Experience working within innovative pharmaceutical companies, focusing on non-generic products.
• Flexibility to collaborate within a regional team and manage evolving responsibilities as part of a broader organizational structure.

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.