Manager, Regulatory Affairs - United Kingdom

As a Manager of Regulatory Affairs, you are responsible for arranging the provision of regulatory expertise and executing regulatory strategies and activities. This includes managing contact with and submissions to local Health Authorities, overseeing product information and artwork, and ensuring regulatory compliance with Astellas policies, regional/local regulations, and the registered dossier. Additionally, you will be responsible for the review and approval of promotional materials.
You will be part of an inclusive team that works to develop innovative therapies for patients.
Hybrid Working:
At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.
Key Activities for this role:

• Ensure timely preparation, submission and follow-up of regulatory applications to ensure maintenance of UK marketing authorizations including preparation of regional-specific documents. Execute tasks related to EU licenses.


• Lead on national UK regulatory submission strategy including advising on optimal labelling, (EAP) Expanded Access Program / (CDx) Companion Diagnostics. Contribute to overall submission strategy planning & execution for non-EU markets. E.g. international collaboration/expedited pathways.


• Product information & artwork management. Provide advice to regional (RA) Regulatory Affairs on label strategy.


• Lead on (GxP) Good Practice inspection readiness & representation. Dual hat with (QA) Quality Assurance/(PV) Pharmacovigilance.


• Review and approve (certify) promotional materials with an in-depth understanding of the code.


• Submit promotional materials to the Health Authority.
  
  Extensive experience in Regulatory Affairs.


• Knowledge of Regulatory landscape and procedures within the UK/EU including directly dealing with regulatory agencies.


• Final signature required.


Education/Qualifications:

• MS Degree in Pharmacy or equivalent.


• General Pharmaceutical Council (GPhC) qualified pharmacist in the UK.
  
  Manager, Regulatory Affairs - United Kingdom

About Astellas:
At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.
Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It's a culture of doing good for others and contributing to a sustainable society.
Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn't a buzzword - it's a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.
We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.
Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.
The Opportunity


• This is a permanent, full-time position.


• Position is based in Addlestone, UK office.


• This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per month in our UK office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.


What We Offer:

• A challenging and diversified job in an international setting.


• Opportunity and support for continuous development.


• Inspiring work climate.