Associate Director, Regulatory Affairs Uk

Job Description**
About This Role**
The Associate Director, Regulatory Affairs UK & Ireland will be responsible for leading and maintaining all 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 Head of the International Regulatory Sciences EU+, Regulatory Affairs Regional Country Management, the relevant International Regulatory Science functions as well as with various local functions such as the Country Managing Director and other functions such as Medical, Marketing and Market Access as well as Quality Assurance. As Associate Director Regulatory Affairs, you will have close interactions with a variety of external stakeholders which may include industry trade associations, regulatory authorities, governmental and public bodies.
**What You’ll Do**:

- Work in close partnership with relevant affiliate staff; lead 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); lead country regulatory maintenance of approved centralized products; managing the centralized labelling process within the timelines; 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
Be involved in post-Brexit regulatory legislation updates and activities, have a good understanding of the implications on a local Regulatory environment and ability to continuously support the local business
- Operational delivery and compliance with local in-country regulatory responsibilities (including budget and people / vendor management) including but not limited to ensuring audit / inspection readiness
- Attend relevant meetings with key international functions and represent local regulatory in-country needs: Regulatory Affairs, Commercial, Market Access and Drug Safety
- Serve as in-country voice to local regulatory agencies and represent Biogen on local Trade Associations and Regulatory Groups
- Act as the company liaison for Horizon Scanning activities
**Who You Are**
You are a passionate and experienced Regulatory Affairs professional with an understanding of Regulatory requirements within the UK, in a post-Brexit setting and requirements in other EU 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

Qualifications**
Required Skills**
- Solid and proven experience working in the Regulatory field of the (bio)pharmaceutical industry
- Degree in Life science or related field
- Experience working within a UK&I affiliate
Ability to independently manage a small team of regulatory affairs staff
- Ability to navigate through ambiguity
- Excellent verbal and written communication skills
- Strong business acumen
- Ability to prioritise according to business needs, while maintaining oversight and keeping focused on deadlines

Additional Information**
Why Biogen?**
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.