Director, Legal Regulatory

Director, Legal Regulatory

About Astellas:

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

We pursue innovative science, focusing 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.

About this job:

In this position, you will provide strategic Legal Regulatory advice to various teams across Astellas, including Brand Teams, Global Value teams, and Core Medical Teams. This strategic position involves balancing global development and commercial opportunities with legal and compliance risks to minimize exposure and reputational damage, particularly focusing on market access and pricing strategies globally, ensuring alignment with the Corporate Strategic Plan, and proactive risk identification and mitigation.

Your main responsibilities would be:

• Providing comprehensive legal and regulatory support globally for diverse functions and stakeholders, such as the Global Commercial Teams, Strategic Brand Marketing, Development, Market Access, and Pricing, Medical Affairs, and Business Development, focusing on Medical Specialties, and legal matters.
• Supporting commercial Medical Specialties' global brand teams by reviewing and approving brand plans, promotional materials, and strategic planning tools, and actively managing crises.
• Furnishing legal and regulatory support to global Medical Specialties and Medical Affairs teams, including the approval of core medical plans, guidance on investigator-sponsored research, and assistance with publication planning.
• Extending legal and regulatory support to global Medical Specialties Development teams, involving the review and approval of strategic planning tools, advice on clinical trial data release, and guidance on regulatory aspects of collaborative research projects.
• Developing and implementing unified global legal strategies, planning, policies, and processes for Medical Specialties with a focus on market access and pricing.

Essential Knowledge & Experience:

• Proven experience gained in law firms or pharmaceutical legal departments in terms of professional experience with a focus on European pharmaceutical regulations concerning the advertising and promotion of medical products.
• Previous experience or a governmental background with pharmaceutical regulatory bodies, especially familiarity with the European Medicines Agency (EMA) would be perceived as a major asset.
• Showcasing strong legal skills and leadership qualities, including extensive experience and knowledge in pharmaceutical legal matters.
• Highlight strong negotiation and communication skills (oral and written) for effective interaction on legal issues.

Education/Qualifications:

• Law Degree, LL.M., or equivalent qualification as part of educational and professional qualifications

Additional information:

• This is a permanent, full-time position.
• Location: Addlestone (UK), although alternative locations may be considered
• This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our Addlestone office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.

We offer:

• A challenging and diversified job in an international setting
• Opportunity and support for continuous development
• Inspiring work climate
• A competitive and attractive salary package to ensure that our employees are fairly rewarded for their contributions and dedication.

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