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Description
ROW Implementation Labelling Lead (RILL)
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 the ROW Labeling Manager, you will be accountable for the development, implementation, and change control of both new and updated labelling for designated Astellas products and regions. The position ensures adherence to Company Core Data Sheets, relevant regional health authority regulations, internal policies, and business objectives. You will be researching government labelling and packaging initiatives to ensure Astellas meets adoption timelines. The role involves extensive collaboration outside of the Regulatory Affairs team to address complex matters and queries. A positive working relationship is maintained with global internal stakeholders and business partners.
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 Responsibilities
- Leading labelling development teams for regional product launches and ensuring all labelling is meeting company and regulatory health authority specifications.
- Managing English Master files and translating text into local languages based on individual country requirements (where appropriate).
- Serving as leader of cross-functional labelling review team meetings; organising, compiling, and maintaining all documentation, and assuring compliance of manual and electronic label history files.
- Assuring compliance of local labelling by evaluating all CCDS/CCSI changes and implementing according to prescribed timelines.
- Advising cross-functional teams on labelling content consistency and best practices for planning and execution.
- Collaborating with Regulatory Leads on submission and implementation strategy for labelling.
- Actively supporting the systems, processes, and operations for developing and changing labelling, and assuring compliance with established procedures.
- Establishing strong working relationships with global stakeholders, affiliates, and business partners, assuring compliant and timely implementation into business supply.
- Making and executing challenging decisions based on sound regulatory knowledge, while recognising when a decision requires escalating to upper management for further consideration. Keeping management informed of critical issues potentially impacting organisational success.
Essential Knowledge And Experience
- Demonstrated experience in the pharmaceutical industry within Regulatory Affairs.
- Hands-on expertise in pharmaceutical labelling development, with a solid track record in managing change control processes.
- Strong knowledge of health authority regulations and guidelines (e.g., ICH) related to labelling development, implementation, and compliance, with the ability to apply this understanding to business needs.
- Proven ability to work effectively with stakeholders across the labelling lifecycle, from content creation to commercial supply.
- Capable of influencing peers and cross-functional partners at all levels while maintaining collaborative and productive working relationships.
- Well-developed organisational skills and keen attention to detail, with the capacity to manage multiple complex and varied projects at the same time.
- Excellent written and spoken communication skills, effective with both native and non-native English speakers.
Preferred Experience
- Scientific understanding of chemistry and general biological or physical sciences, with the ability to apply that knowledge to complex regulatory matters and technically detailed product development.
Education
- Bachelor’s degree in a scientific field such as Biology, Biotechnology, Biochemistry, or Chemistry; an advanced degree is preferred or equivalent.
Additional Information
- The is a permanent full-time position based in the UK.
- This position follows our hybrid working model. Role requires a blend of home and a minimum of 2 days a month in our Addlestone office. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office.
