Our Client:

A pioneering pharmaceutical company with strategic operations in Dublin and part of a renowned global Fortune 500 organisation. 

The Opportunity:

• Join a strategic Dublin operation as Head of Legal at a pivotal time in its growth cycle.  
• Enjoy parent support from one of the world's most successful brands
• Shape, mould, and lead the Irish legal division
• Act as Legal Business Partner to the organisation 
• Join a collaborative, personable, dynamic team 
• Command a highly competitive remuneration package 
• Hybrid working - city centre Dublin office 

• Provide clear, pragmatic technical legal and regulatory advice to the business regarding the interpretation and application of the relevant legal and regulatory requirements. 
• Research, review and advise the business on any relevant supervisory authority’s regulatory requirements e.g HPRA requirements, Wholesale Distributor Authorisation framework
• Correspond and successfully build relationships with relevant supervisory authorities as required. Research, prepare, submit and manage any relevant authorisation applications and/or submissions.
• Responsible for the management and successful delivery of all legal and regulatory projects in a fast-paced, regulated environment.
• Collaborate with all relevant internal and third-party stakeholders as required to review, draft and negotiate a wide range of commercial contracts across multiple jurisdictions.  Ensure contracts comply with corporate policies and procedures, data privacy, security regulations, and audit requirements leveraging from existing precedents/ practices and fellow US in-house legal peer expertise.
• Agreements include Confidentiality Agreements, CMO agreements, Vendor Agreements, Product development agreements, Strategic partnership agreements, Quality/technical agreements, Distribution Agreements, and Co-Branding agreements.
• Ensure and maintain a robust and fit-for-purpose suite of data privacy policies and procedures for the organisation in line with GDPR and update the business and colleagues as appropriate.
• Assist and advise on relevant commercial and company law matters. 
• Advise on any potential company re-organisation and/or M&A activity. 
• Act as company secretary for the Irish entity taking responsibility for all corporate governance matters across the company.
• Foster and develop productive relationships with key stakeholders and business units, acting as a trusted legal advisor. 
• Manage relationships and budgets with external counsel as required.
• Advise and assist on ad hoc projects and issues as they arise. 

• Qualified lawyer. Minimum of 10 years’ PQE.
• Prior pharmaceutical industry experience.
• Relevant pharmaceutical industry regulatory experience including the Health Products Regulatory Authority regime. Wholesale Distributor Authorisation process experience is advantageous. 
• Excellent contract drafting, review and negotiation skills as discussed.
• Experience advising on GDPR in a global organisation setting. 
• Experience providing commercial, pragmatic to an organisation on a range of relevant legal and regulatory issues as and when required. 
• Proven ability to positively engage with and influence relevant stakeholders - both internal and external.
• Strong team player but also self-motivated and strong decision-maker.
• Excellent attention to detail and highly analytical.
• Adaptable, and proven ability to multi-task in a fast-paced, global environment.
• Commercial and solutions-focused. 

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