Regulatory Affairs Director

Location: Barcelona - Spain (3 days working from the office and 2 days working from home) Introduction to the role The RAD p rovides strategic and operational regulatory leadership to the development,   commercialisation   and life cycle management of the assigned product(s).   The RAD s erve s   as   the global regulatory lead ( GRL )   on   early stage   projects or specific indications of   larger programs , or as regional   regulatory lead . Contributes significantly to overall product and clinical strategy.   The role plays a key role   i nfluenc ing   Regulatory authorities through regular contacts to improve Regulatory outcomes.   The RAD leads   cross -   functional Teams in major Regulatory Submissions (NDA, IND/CTA), Health Authority Interactions,   Label d iscussions, and securing   NDA/BLA   Approvals.   As a GRL the RAD leads the   Global   Regulatory   S trategy   T eam   (GRST)   in formulating Global Regulatory strategy and delivering on NDA Filings and Approvals.   Alternatively, as a regional regulatory lead, the RAD is a member of the GRST and is accountable for providing the region-specific Regulatory strategy and advice.   The RAD s erve s   as the face of the company with Health Authoritie s.   Typical Accountabilities    • A ccountable for leading the development and implementation of the regional or global regulatory strategy for a product/group of products.   E nsure s   that the strategy is designed to deliver rapid approval with competitive labeling in keeping with the properties of the product(s) and the needs   identified   by the business,   markets   and patients. This includes   health   authority engagement strategy and considerations of expedited regulatory programs.   • Lead cross-functional Teams in   major health authority interactions. This includes   setting   the strategy and planning for the interaction, driving the formulation of the briefing document focused on strategy and scientific content, leading the team through   meetings   rehearsals, and moderating the meeting itself.   • L ead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team.   Participate in coaching, and performance feedback to members of your GRST.   • May (depending on role and project) represent Regulatory Affairs on Global Product Teams (GPTs)   providing   strategic Regulatory advice and be accountable for all Regulatory activities   • A ccountable for the delivery of all regulatory milestones on your team including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations.   L ead preparation of the regulatory strategy document and target product labeling.   • Demonstrate   strategic leadership skills contributing to effective product development.   P rovide team leadership and   participate   in coaching, and performance feedback to members of   the   GRST.   • A ccountable for initiating and delivering key regulatory documents and plans and leading the negotiations with health authorities.   • L ead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities.    • E nsure s   appropriate planning   and construction of the global dossier and core prescribing information led by the respective teams.    A ccountable for product maintenance, supply and compliance activities associated with marketed brands.   • P artner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.     Education, Qualifications,   Skills   and Experience   Essential   • An advanced degree in a   science related   field and/or