Associate Director, EUCAN (Europe & Canada) Regulatory Affairs
Strategy Lead, Marketed Products
- Collaborates to define, develop and lead regional strategies to maximize regulatory and patient access success to enable 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.
- Provide regulatory expertise for multiple projects and/or one highly complex project for assigned development project of responsibility.
- Mentors team members, if required, to support scope of project work.
- May be called upon to act as deputy to the regional therapeutic area lead and/ or Region regulatory head, attending internal leadership team meetings, as appropriate
- Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to project areas and/ or region of responsibility enabling proactive approach and planning to future business requirements.
- For centralized products is the primary EMA contact for project(s)/products of responsibility or can delegate with oversight. Informs the business. Manages interactions with EMA and national health authorities (and HTAs jointly with value and access team in context of parallel consultation) in the Europe Union and European Economic Area for specific product(s).
- Leads the regulatory working team for Europe region submissions and represents as needed at project team and ensures regional regulatory lifecycle management strategy and submission planning written and executed according to plan –
- Partner with the regional/LOC market access and LOC RA colleagues to understand market access and reimbursement topics and support opportunities to drive consolidated inputs into regional product development plans.
- For the project(s)/product(s) of responsibility, collaborates with Global and Regional colleagues for the authoring of global regulatory strategies and ensures own critical deliverables as agreed within the global regulatory strategy and planning.
- Accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within region (s) of responsibility (E.g. EMA submissions for Europe). 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 or may delegates oversight.
- Leads and manages meetings and / or interactions with regulatory authorities and agency meetings.
- Regulatory reviewer in due diligence for licensing opportunities, development and /or marketed product opportunities.
- 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.
- Identifies and proposes solutions to the management of resource gaps for areas of responsibility.
- Presents to senior management as requested.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BSc degree or equivalent in science; advanced degree preferred
- Considerable 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.
- Ideally some experience of working oncology products
- Solid working knowledge of regulations and guidance governing drugs and biologics in all phases of development, including post-marketing, in EU (A good understanding of basic regulatory requirements in emerging markets preferred. Awareness of evidence requirements beyond the regulators (e.g. HTA bodies)
- Understands and interprets complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
- Preferred experience in managing major regulatory filing(s); and significant contributor to regulatory and/or development strategies
- Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Generally strong and independent skills 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 and within global teams; and acceptable at communicating with senior leadership
- Generally strong leader who is effective manager and is able to bring working teams together for common objectives. Able to mentor and develop skills of team members.
- Experience in managing personnel a plus; experience managing relationships with CROs and/or contractors also preferred.
- Willingness to travel to various meetings, including overnight trips.
- Requires approximately up to 10-30% travel.