Associate Director, Regulatory Legal - United Kingdom
Want to know company name or location? Company managed [?]
- We currently have any opportunity for a qualified lawyer to work within our inhouse EMEA legal team supporting our Medical and Deveopment function and in particular our Regulatory & Development group.
- This is a specialized role encompassing the management of a broad range of stakeholders both at an EMEA and global level with a significant impact on business decisions and outcomes across the EMEA region.
- The job holder will work in alignment with the Executive Director for this area and will be responsible for balancing commercial opportunities with associated legal and compliance risks in a complex and fast evolving regulatory environment.
- Provide legal advice and support to the Medical & Marketing/Brand functions for defined therapeutic areas working as a business partner
- Assist with the Approval of Brand Plans and strategic planning tools for major brands and therapeutic areas
- Provide support and advice throughout the lifecycle of products from early development to launch
- Manage the resolution of marketing and promotional disputes and assist with publication planning
- Draft, review and negotiate a variety of third party and Clinical Trial Agreements alongside Scientific Exchange and Clinical trial data release
- Partner with medical teams on approval of Core medical plans and strategic planning tools for major brands
- Advise on Investigator Sponsored Research (ISR) activities and represent the EMEA Legal function on ISR oversight team
- Provide expertise on legal compliance issues relevant to Marketing & Medical functions e.g grants and donations patient support programmes etc
- Attend congresses to monitor competitor activity and support company team in any alleged non-compliant activity
- Support internal and external investigations and respond to external agency inspections/audits
- Supports regional and global projects that involve complex or difficult issues requiring a high degree of legal skill and business acumen including often difficult judgments on contested areas and issues
- Qualified lawyer , able to evidence good knowledge and experience in the legal environment related to the marketing and distribution of pharmaceuticals and product life cycle management, either as a corporate lawyer or from within a law firm
- Knowledge and understanding of key business, legal and compliance issues within pharma and life science industry
- Experience in drafting and negotiating of clinical trial, non-interventional study and ISR agreements
- Hands-on experience of working in multi-functional, cross-cultural teams
- Experience of leading legal support in global project teams
- Able to influence at all levels within the organisation and build trust and credibility with the EMEA Leadership team