Manager / Senior Manager, EU Regulatory Lead, Rare Genetic & Hematology

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Job Description

OBJECTIVE:

• 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.
  A minimum of 4-6 years of pharmaceutical industry experience. This is inclusive of 2-5 years of regulatory experience or combination of 4-6 years regulatory and/or related experience.
• 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.

At our heart we are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, sexual orientation, race, colour, ethnic or social origin, or disability.Our team is growing and for this we need bright minds with creativity and flexibility – what talent do you have?

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