Manager, Regulatory Affairs UK & Ireland
- Maidenhead, United Kingdom
- Department: Regulatory
- Region: EU+/Canada
About This Role
Joining us as Manager, Regulatory Affairs UK and Ireland, you will be responsible for supporting and maintaining assigned country European Regulatory and R&D compliance activities across the product portfolio in line with the company’s strategy and the management of benefit/risk activities. You will work closely with the in-country Regulatory lead, relevant International Regulatory Science functions as well as with various local functions such as Medical, Marketing and Market Access as well as Quality Assurance. As Manager RA UK & I, you will have close interactions with external regulatory authorities, advisory committees and cooperative groups.
What You’ll Do
- Work in close partnership with relevant affiliate staff; in alignment with in-country Regulatory lead, lead dedicated local regulatory activities for the affiliate to contribute to early-stage pipeline and marketed product changes as appropriate
- Pre- and post-approval of European labelling activities together with contributing to the European Regulatory Strategy (input to early and late phase projects, marketed products); collaborate in country regulatory maintenance of approved centralized products, managing the centralized labelling process within the timelines and oversee review and approval of label, packaging and artwork
- Maintain country and international stakeholder communication and relationship plans and optimize working relationships
- Maintain current awareness/information pertaining to local affiliate requirements, gain regulatory intelligence within the country and contribute to Central Regulatory Intelligence function
- Maintain comprehensive current knowledge and apply national requirements and guidelines for activities such as promotional materials, early access programme's, wholesale dealers, license, Phase IV or market access trials, membership in trade associations or national bodies
- Ideally, you will have been involved in BREXIT preparations, have a good understanding of the implications on a local Regulatory environments and ability to prepare the local business
- Operational delivery and compliance with local in-country regulatory responsibilities (including budget and people / vendor management)
- Serve as in-country voice to local regulatory agencies and represent Biogen on local Trade Associations and Regulatory Groups
Who You Are
An experienced Regulatory Manager with an understanding of Regulatory requirements in a wide range of regions/countries. You are someone who possesses a strong business and commercial acumen. You are not afraid to challenge decisions and put forward alternative solutions to complex problems.
- Strong experience working within the Regulatory field of the Biotech/Pharmaceutical industry
- Proficient in MS-Office, web applications, Regulatory relevant databases (e.g. intelligence tools such as Cortellis), as well as Electronic Document Management Systems and electronic review systems
- Ability to work independently
- Excellent communication skills
- Bachelors Degree in a life science or similar discipline, preferred
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.