Our client Takeda Pharmaceutical Company Limited is a leading global, value-driven, research-based biopharmaceutical company headquartered in Japan. In Austria, Takeda operates along the entire pharmaceutical value chain: research & development, plasma collection, manufacturing and distribution. Takeda is the largest pharmaceutical employer in Austria. Every day, around 4,500 employees help to ensure that medicines from Austria reach the whole world and that patients all over the world have access to innovative medicines from Takeda. The Austrian product portfolio helps patients in the fields of oncology, hemophilia and genetic diseases, gastroenterology and immunology, among others. In 2020 and 2021, Takeda was recognized as a Top Employer and Great Place to Work in Austria.
To further strengthen the local EU Regulatory Affairs Strategy Team, at the site in 1220 Vienna, Takeda is seeking for a
EU Regulatory Affairs Strategy Product Lead | Manager (f/m/x)
with experience in EU Regulatory Affairs, including experience in Life-Cycle Management, Marketing Authorisation Applications, Paediatric Investigation Plans, Orphan Drug Designations, rare disease drug development or expedited regulatory pathway.
About the job:
The EU Regulatory Affairs Strategy Product Lead, 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 registration, commercialization and lifecycle management of Plasma-Derived Therapies in the European Union, Great Britain, Switzerland, South-Eastern Europe, Israel, and Palestine
- Serving as subject matter expert and participates in the Global Regulatory Team (GRT) composed of core regulatory support functions
- Representing EU RA Strategy at internal and external stakeholders
- Serving as a liaison to the European Medicines Agency (EMA) or National Competent Authorities and providing support for local Regulatory Affairs teams
- Preparation, review and approval of regulatory filings to support the maintenance or expansion of approved Plasma-Derived Therapies
- In partnership with line manager proactively identifying and assessing regulatory and compliance risks associated with product development and life-cycle management activities
- Developing and fostering appropriate relationships with the European Medicines Agency and European Competent Authorities to develop effective, professional relationships and advance a positive company image
- Minimum of 5 years of experience in drug/biologics development in the pharmaceutical or biotechnology industry with at least 3 years of experience in a Regulatory Affairs role
- 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
- Competence to interpret 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 regulatory plans
Skills that will help you in the role:
- Ability to apply precedent and previous experience to develop innovative and flexible approaches to achieving commercial goals
- Good communicator, able to convey ideas verbally and in writing
- Capacity to manage diverse cross functional teams
- Proficiency in developing executable plans and meeting budget and deadlines
- Proven skills as an effective collaborator who can engender credibility and confidence within and outside the company
- A responsible role in an internationally successful company, with an open communication culture and appreciative interaction
- Look forward to a fair supervisor and a dynamic environment
- Work @ home possibility
- In-house Canteen with discounts or meal vouchers
- Free health check-ups and preventive vaccinations incl. general care by the occupational health service
- Gymnastics courses, strength training and massage in the in-house fitness and wellness center
- Company kindergarden
The minimum salary for this position is € 5.222,35 gross per month (full time 38 h/week, All-In, collective wage agreement for the chemical industry), due to your professional experience and your qualifications an increased payment is intended. The contract will be limited for 1 year, an extension of the contract is possible.
If you are interested in finding out more about this position, please send your informative application via www.randstad.at.
We draw your attention to the fact that your application documents in their entirety, including all personal data contained therein, will be forwarded to Takeda for the purpose of carrying out the application procedure and the pre-selection.