Manager, Regulatory Affairs - United Kingdom

About Astellas:

At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.

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.

We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

The Opportunity:

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.

Essential Knowledge & Experience:

• 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.

Additional Information:

• 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.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.