The EU Regulatory Strategy Lead, Global Regulatory Affairs Strategy, Plasma-Derived Therapies Business Unit (GRA PDT BU) works under the direction of the Head EU Regulatory Affairs Strategy to develop and implement regulatory strategies, objectives and policies pertaining to the development, registration, commercialization and lifecycle management of Plasma-Derived Therapies in the EU. This role serves as the EU regulatory affairs lead for one or more projects and participates in the Global Regulatory Team (GRT) composed of core regulatory support functions. The position will provide leadership support to the Head EU Regulatory Affairs Strategy. The EU Regulatory Strategy Lead serves as a liaison to the European Medicines Agency (EMA) and National Competent authorities and will provide support for local regulatory affairs teams.
In partnership with others, provides proactive guidance and leadership, to develop and implement innovative regulatory strategies for the European Union, GB, CH, SEE, Israel, and Palestine. This is to occur in close collaboration with relevant PDT BU, PDT R&D and EUCAN Commercial functions to obtain, maintain and extend Takeda PDT BU product registrations in the European Union, GB, CH, SEE, Israel, and Palestine and under the overall direction of the Head, EU Regulatory Affairs Strategy.
Establishment and maintenance of European Union, GB, CH, SEE, Israel, and Palestine regulatory strategy plans in close coordination with the PDT BU Global Regulatory Strategy and CMC Regulatory Affairs functions, and the Takeda Payer Value and Patient Access function.
Provides support for local regulatory affairs teams for interactions with European Union, GB, CH, SEE, Israel, and Palestine regulatory Agencies.
Serves as the European Union, GB, CH, SEE, Israel, and Palestine regulatory strategy subject matter expert for assigned projects. Provides proactive guidance to Takeda PDT BU R&D and Takeda R&D internal functions based on technical and regulatory knowledge. Proactively identifies, assesses, and mitigates regulatory risks associated with product development and maintenance for assigned projects.
Participates in Global Regulatory Team and represents PDT BU EU regulatory affairs on select internal program teams.
Drives the tactical implementation of strategic regulatory plans for the creation and submission of regulatory documents, e.g., CTA, MAA, ODD, PIP and other relevant European Union, GB, CH, SEE, Israel, and Palestine regulatory filings.
Develops and implements European Union, GB, CH, SEE, Israel, and Palestine regulatory strategies to obtain and maintain CTAs and MAAs, and to extend product registrations.
Coordinates and supports the design and implementation of European Union, GB, CH, SEE, Israel, and Palestine regulatory strategies to obtain, maintain and to extend product registrations in the European Union, GB, CH, SEE, Israel, and Palestine.
Drives the creation of high quality, compliant regulatory documents within defined timelines as per Takeda PDT BU objectives.
Serves as direct liaison to the EMA and national Competent Authorities in the EU and leads Authority meetings, amd provides support for local regulatory affairs teams for interactions with European Union, GB, CH, SEE, Israel, and Palestine regulatory Agencies.
Remains knowledgeable about current EU regulations and guidance and interprets the EU regulatory environment to
provide proactive guidance to internal stakeholders based on technical and regulatory knowledge and to guide the development of strategic and tactical European Union, GB, CH, SEE, Israel, and Palestine regulatory plans. Responsible for preparation, review and approval of European Union, GB, CH, SEE, Israel, and Palestine regulatory filings to support early and late stage development assets, and the maintenance or expansion of approved Plasma-Derived Therapies in the European Union, GB, CH, SEE, Israel, and Palestine. Proactively identifies and assesses regulatory and compliance risks associated with product development and life-cycle management activities.
Proactively develops and fosters appropriate relationships with the European Medicines Agency and European competent authorities to develop effective, professional relationships and advance a positive company image.
In partnership with other relevant functions, assists in the conduct of EU regulatory agency inspections and compliance audits. Helps ensure compliance in all GRA PDT BU activities.
Acts as an ambassador for the Takeda PDT BU Regulatory Affairs organization to influence and shape the external regulatory and policy environment.
Your Skills and Qualifications:
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work – life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer. For more insights into Takeda click here.
We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.
Motivated employees must be remunerated appropriately. The minimum salary for this important and responsible position is € 4.439,- gross per month (full time, collective wage agreement for the chemical industry). The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.