Manager, Eu Regulatory Affairs Strategy Product

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 (Manager), Plasma-Derived Therapies Business Unit, is a key role in Global Regulatory Affairs and works under the direction of the EU Regulatory Affairs Strategy Team Lead and is:

- Responsible for proactive development and implementation of regulatory strategies, objectives and policies pertaining to the development, registration, commercialization and lifecycle management of Plasma-Derived Therapies in the European Union, Great Britain, Switzerland, South-Eastern Europe, Israel, and Palestine
- Representing EU RA Strategy at internal and external stakeholders
- Serving as a liaison to the European Medicines Agency (EMA) and National Competent Authorities and providing support for local Regulatory Affairs teams.

**Your Opportunities**:

- Provides proactive guidance and leadership to develop and implement innovative regulatory strategies. 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.
- Leads the establishment and maintenance of EU 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.
- 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 regulatory filings.
- Serves as direct liaison to the EMA and national Competent Authorities in the EU and leads Authority meetings under the guidance of the EU Regulatory Affairs Strategy Team Lead and provides support for local Regulatory Affairs teams for interactions with national Regulatory Agencies.

**Your Skills and Qualifications**:

- Minimum of 2 years of experience in EU drug/biologics development in the biopharmaceutical or biotechnology industry or Government Health Authorities with at least 1 year 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
- Knowledge of EU regulatory requirements and ability to interface with the EMA and European Competent Authorities
- 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**.

Motivated employees must be remunerated appropriately. The minimum salary for this important and responsible position is € 3557,47 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.

**Locations**:
AUT - Wien - DC Tower

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time