Job Description

About This Role

This role will act as a point of contact within the Regulatory and Artwork teams for initiating artwork for new products, and for coordinating and enabling implementation of artwork changes for EU marketed products. As this includes all components for packaged pharmaceutical products, you will develop a deep understanding of regulatory requirements for all patient and physician facing materials.  You will also become familiar with the process, including the interplay between supply of product and artwork, and European regulatory applications and timelines (marketing applications and variations to these), to ensure artwork is delivered on time. 

What You’ll Do

As the responsible Regulatory contact in a cross functional artwork team, you will lead change management meetings and review artwork, have responsibility for the Regulatory assessment, together with the EU regulatory lead, and be accountable for internal system updates (BEAMS, GRIT, PLM). Your input will be critical to the improvement of internal processes over time.

As the role develops, there will be opportunities to assist in the planning and preparation of regulatory submissions relevant to assigned projects with guidance from the EU Regulatory leads.

Over time you will support a number of products and act as a point of contact with the artwork team, to help ensure consistency and increase compliance.  A point person can advise and support products as they transition from pre-approval to post-approval space ensuring that EU RLs can support the key activities including cross-functional discussions and implementation.   

Who You Are

A motivated and proactive graduate who is looking for a career in regulatory affairs, interest in EU market regulations.  Strong organisational and project management skills; team player; strong communicator cross-functionally and cross-culturally; interest in digital data management systems; interest in working with business functions.

Qualifications

• A recent postgraduate degree in life sciences.
• Proficient computer skills with the Microsoft suite of products, primarily Word, Excel, PowerPoint
• Fluent in English, with strong written and verbal communication skills

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.