Senior Manager, EUCAN Regulatory Lead, GI応募後で応募 求人ID R0035211 掲載日 06/15/2021 Location:Zurich, Switzerland
- 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.
- 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 GI and/or NS 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.