The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. There are two main drivers of innovation that are the focus of the PDT R&D organization: Translational Pharmaceutical Sciences and Precision Medicine.
The EU Regulatory Affairs Strategy Product Lead (Director), Plasma-Derived Therapies Business Unit (PDT BU) is a key role in EU RA Strategy and works under the direction of the Head of EU Regulatory Affairs Strategy.
- Provides proactive guidance and leadership, to develop and implement innovative regulatory strategies. This is to occur in close collaboration with relevant different Business Unit's 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.
- Leads the 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 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.
- Serves as direct liaison to the EMA and national Competent Authorities in the EU and leads Authority meetings and provides support for local Regulatory Affairs teams for interactions with European Union, GB, CH, SEE, Israel, and Palestine Regulatory Agencies.
Your Skills and Qualifications:
- Minimum of 10 years of experience in EU drug/biologics development in the biopharmaceutical or biotechnology industry, or Government Health Authorities with at least 6 years of experience in a Regulatory Affairs role.
- Experience in plasma-derived therapies and biologics preferred.
- Bachelor’s or Master’s degree required. Advanced scientific or health sciences degree or equivalent relevant experience preferred.
- Highly extensive knowledge of EU regulatory requirements and ability to interface with the EMA and European Competent Authorities.
- High ability to use precedent and previous experience to develop innovative and flexible approaches to achieving commercial goals.
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 € 4 527,78 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.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, and any other characteristic protected by law.
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