Senior Manager Regulatory Affairs UK Ireland
Senior Manager Regulatory Affairs UK Ireland
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Salary Not Disclosed
1 Vacancy
Job Description
About This Role
Joining us as a Senior Manager Regulatory Affairs UK & Ireland you will be responsible for supporting and maintaining countryspecific regulatory and R&D compliance activities across our pipeline and product portfolio in line with the companys strategy and the management of benefit/risk activities. You will play a key role driving regulatory strategies in alignment with business objectives in addition to ensuring compliance.
In this role you will work closely with the incountry Regulatory Head Global Regulatory Affairs colleagues and R&D teams as well as with various local functions such as Medical Marketing Market Access and Quality Assurance. You will have close interactions with external regulatory authorities advisory committees and cooperative groups.
This is a hybrid role requiring attendance at our Maidenhead offices 23 days per week.
What Youll Do
- Lead and support local regulatory activities for the UK/Ireland affiliate reporting through the Global Regulatory Affairs (GRA) group.
- Manage pre and postapproval procedures for pipeline and marketed products including orphan applications ILAP PIPs Scientific Advice EAMs MAA filings and postapproval maintenance.
- Oversee local labelling processes and ensure timely updates for centralized products in Ireland.
- Review and approve packaging artwork and educational materials.
- Maintain strong relationships with regulatory authorities advisory committees and industry groups.
- Monitor and provide insights on regulatory intelligence to support business strategy.
- Ensure operational compliance with incountry regulatory responsibilities.
- Represent Biogen in local trade associations and regulatory groups as needed.
Who You Are
You are an experienced regulatory affairs professional with strong experience in the UK and Ireland regulatory landscape. You excel at working collaboratively across teams building relationships with key stakeholders and ensuring regulatory compliance. You have a strategic mindset and the ability to navigate complex regulatory requirements effectively.
Qualifications :
Required Skills
- Strong and proven experience in Regulatory Affairs within the (bio)pharmaceutical industry.
- Strong understanding of UK and Ireland regulatory frameworks.
- An excellent communicator with the ability to lead strategic cross functional team discussions
- Proficiency in MS Office regulatory databases (e.g. Cortellis) and electronic document management systems.
- Ability to work independently and manage multiple priorities.
Additional Information :
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished 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 lifechanging 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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
