Legal Counsel, Product Development & Manufacturing and Pharmacovigilance (Senior Director)

General Information

Job Advert Title Legal Counsel, Product Development & Manufacturing and Pharmacovigilance (Senior Director) Location Ireland, United Kingdom Function/Business Area Legal, Risk, Ethics & Compliance Employment Class Permanent

Description

Legal Counsel - Product Development & Manufacturing and Pharmacovigilance (Senior Director)
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 Legal Counsel - Product Development & Manufacturing and Pharmacovigilance, you will provide senior‑level legal support across Astellas’ global Product Development & Manufacturing (PDM) organisation and serve as the primary legal partner for our global Pharmacovigilance Functional Unit.
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.
Responsibilities:

• Serve as the strategic legal advisor to PDM across a wide range of commercial manufacturing and supply‑related activities, supporting operations including three manufacturing sites in Ireland. 
• Partner closely with senior PDM leaders, providing proactive legal counsel and helping shape strategic decision‑making. 
• Monitor and interpret legal developments within the pharmaceutical industry, especially manufacturing and supply chain, and advise stakeholders accordingly
• Draft, negotiate, and execute a broad range of complex commercial agreements, including contract manufacturing agreements, testing service agreements, engineering agreements, construction service agreements, purchase agreements, commercial supply agreements, quality agreements, and services agreements for supply chain vendors.
• In addition to PDM related support, serve as main operational and strategic support to the global Pharmacovigilance team, providing legal support as needed.

Essential Knowledge & Experience:

• Qualified lawyer with significant life science and/or manufacturing experience.
• Proven track record a