Collaborates to define, develop and lead 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 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 project(s) within the therapeutic area of responsibility
Manages and oversees interactions with EMA and national health authorities and HTAs (jointly with value and access team in context of parallel consultation) in the Europe Region for products within their responsibility
Ensures regional regulatory strategies are written, reviewed and executed according to plan
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 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
Mentors team members, if required
May be called upon to act as deputy to the Regional therapeutic area lead and / or Regional regulatory head, attending internal leadership team meetings, as appropriate
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 Oncology 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
Identifies relevant regional regulatory requirements and provides regulatory guidance, and expertise to internal team on the assigned project(s) of responsibility
Authors and reviews regional regulatory strategies as well as executes day-to-day activities for projects
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
Leads and manages meetings and / or interactions with regulatory authorities and agency meetings negotiates on behalf of project team as necessary.
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.
Proactively builds / strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts / influence to achieve Takeda strategic goals and objectives
Identifies regulatory requirements and trends across area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and / or higher governance bodies in these areas, as requested
Ensures coverage for projects within the therapeutic area identifies possible gaps, and proposes solutions to the management
Identifies and proposes solutions to the management of resource gaps for areas of responsibility
Presents regional regulatory strategies to senior management as applicable.
Educational, Behavioural Competencies and Skills :
BSc. advanced scientific related degree preferred; BA accepted based on experience. Advanced degree preferred
Extensive pharmaceutical industry experience. This is inclusive of thorough regulatory experience or a solid combination of regulatory and / or related experience in both development and / or post-marketing phases.
Solid working knowledge of regulations and guidelines governing drugs and biologics in all phases of development, including post-marketing, in the EU (relevant to role), with a good understanding of basic regulatory requirements in emerging markets.
Understanding of evidence requirements beyond the regulators HTA bodies).
Understands and interprets complex scientific issues across projects and therapeutic area 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 skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability
Able to train / develop junior colleagues in the area of regulatory strategy such as understanding 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.
Additional requirements :
A minimum of 8 years of pharmaceutical industry is inclusive of 6 years of regulatory experience or combination of 8 years regulatory and / or related experience.