Regulatory affairs lead EUCAN GI and inflammation

• Under supervision from a senior team member and/or Line Manager defines, develops and sometimes leads regional strategies to maximize regulatory approvals and patient access to meaningful medicines in alignment with program objectives
• Effectively communicates objective assessments of the likelihood of success of these regulatory strategies
• Provides regional strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements
• Leads the Regional Working Team and represents the region as needed on global and project teams
• Provides regional regulatory expertise for assigned development and /or life cycle management projects within the therapeutic area of responsibility
• Under supervision from a senior team member and/or Line Manager sometimes manages interactions with EMA and national health authorities (and HTAs in context of parallel consultation) in the European Region for product(s) within their responsibility.

ACCOUNTABILITIES:

• Ensures regional regulatory strategies are written, reviewed and executed according to plan
• In alignment with line manager, provides strategic and tactical advice and guidance to allow the timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements
• Manages, plans, and executes regional regulatory submissions within the area of responsibility and ensures timely approvals throughout product development and lifecycle
• Partners with the regional market access and LOC RA colleagues to define the strategy for, and to lead and oversee joint interactions with regional and national regulatory/health agency/HTA bodies on value and evidence topics and to support heath authority decision making
• Collaborates with Takeda Global and Regional counterparts and Integrated Franchise Team (IFT) to ensure the regional regulatory strategy is created and executed upon for all projects within area of responsibility
• Identifies relevant regional regulatory requirements and trends across scope of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas
• Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to area and region of responsibility
• May be called upon to provide direction to senior leadership, as relevant
• Develops and maintains effective working relationships with EUCAN RA and Rare Genetic & Hematology Team members, LOC RA teams, Global Regulatory Teams, Cross-functional Teams; consultants and business partners as required
• Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility
• Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed
• In collaboration with global colleagues, works to resolve regional critical conflicts in global regulatory strategies.
• Authors and oversees execution for more complex regional regulatory strategies as needed
• Under supervision from a senior team member and/or Line Manager, sometimes leads and manages meetings and / or interactions with regulatory authorities and agency meetings; in alignment with line manager can negotiate on behalf of project team as necessary.
• Under supervision from a senior team member and/or Line Manager, sometimes represents Takeda in Health Authority meetings, as required. Effectively communicates and manages meeting outcome and next steps
• May be required to lead and provide regional regulatory input in due diligence for licensing opportunities, development and /or marketed products
• Pro-actively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to support Takeda strategic goals and objectives
• Identifies regulatory requirements across area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and /or higher governance bodies in these areas
• Ensures coverage for projects within the therapeutic area identifies possible gaps, and proposes solutions to the management
• Presents regional regulatory strategies to senior management as applicable

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• BSc. Advanced scientific related degree preferred; BA accepted based on experience. Advanced degree preferred
• Considerable experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and /or post-marketing phases.
• Solid working knowledge of regulations and guidelines governing drugs and biologics in development, including post-marketing in the EU
• Understands and interprets complex scientific issues across projects and therapeutic area(s) of responsibility as it relates to regulatory requirements and strategy
• Preferred experience in managing multiple filings; or managing multiple programs in closely related development area; expertise in the EU region (as relevant to role) with global involvement also preferred
• Generally strong in all basic skills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability
• Able to understand broad concepts within regulatory affairs and implications across the organization and globally
• Proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
• Generally strong in working well with others, within global teams and communicating with senior leadership.
• Takes stand on important issues in productive, respectful way.
• Experience managing relationships with CROs and/or contractors also preferred.