Nordic Regulatory Affairs Manager応募後で応募 求人ID R0034260 掲載日 06/15/2021 Location:Helsinki, Finland
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Nordic Regulatory Affairs Managerin Finland.
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 potentialthroughlife-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and striveforexcellence in everything we do. We foster an inclusive,collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a BrighterFuture topeople around the world.
- Local responsibility for life cycle management of an assigned product portfolio within CP/MRP/DCP and NP by being:
- Responsible for local implementation of regulatory changes for this portfolio (internally and externally) and local launches of new products/indications
- Responsible for applications and implementation of national regulatory changes where applicable
- Primary contact with applicable local national health authority during pending procedures or other product related questions
- The person to ensure national registrations are aligned with global dossier updates and take ownership of regulatory strategies for single country National registrations.
- Provider of relevant local impact assessment of global dossier changes
- Regulatory contact person and member of local cross functional team
- Regulatory Subject matter expert (SME)
CAPABILITIES AND EXPERIENCE:
- Expert knowledge and experience of Regulatory Affairs and authority requirements in EU and Finland, and in other Nordic countries if applicable
- Full life cycle experience, including early access, maintenance and launches. Detailed knowledge of regulatory requirements in national CMC and safety change evaluations
- Ability to work independently as well as working in functional and cross-functional teams
- Proven negotiation and influencing skills, based on can-do attitude
- Finnish and Swedish speaking and writing is preferred
- High level of interest in constant personal development to enable high professional performance
- Experienced in Regulatory IT systems and holds ability to easily adapt new systems/processes
- Min 6 years of experience in pharmaceutical industry, of which at least 4 years in regulatory affairs roles
- Degree in Pharmacy or other life science
- Based in Finland
Empowering Our People toShine
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