Regulatory Affairs Specialist, Nordics

at  Takeda Pharmaceutical

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JOB DESCRIPTION

At our heart we are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity, and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, sexual orientation, race, color, ethnic or social origin, or disability.
Our team is growing and for this we need bright minds with creativity and flexibility – what talent do you have?
For our Nordic Regulatory Affairs team, we are looking for a Regulatory Affairs Specialist, Nordics who will cover RA responsibility across all four countries.
This is fixed term contract from March 2025 until April 2026 for our Norwegian office in Asker, and it is an exciting early career opportunity to explore RA.

ACCOUNTABILITIES

• Performing lifecycle management activities including regulatory applications and updates, launches of new products and new indications.
• Nordic point of contact for a portfolio of inline products for EUCAN RA and in the MCO across Nordics.
• Engagement in the TA community contributing to collaboration and sharing input to support prioritization and resource planning.
• Maintain relationship and communication with local competent regulatory health authorities in the Nordic countries.
• Commitment to regulatory compliance with relevant legal governance, code of conduct, guidelines, and applicable SOPs to ensure inspection-readiness.
• Acting in a defined area as Subject Matter Expert by representing the department, developing the relevant expertise, and sharing insights in Nordic Regulatory
• Preparedness to engage within EUCAN RA with regards to knowledge sharing and collaboration around specific matters
• Back up for Nordic Artwork management team (NAWT)

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

Education

• Academic degree (BSc/MSc) preferable in pharmacy or life science or corresponding experience
• A couple years of experience from the pharmaceutical industry
• Experience from the regulatory environment is preferable. Alternatively, experience from Quality Assurance (QA), or pharmacovigilance (PV)

• Nordic product responsible (NPR) for regulatory lifecycle management of a product portfolio with the purpose to successfully deliver the EUCAN regulatory plans in alignment with agreed business priorities.
• Contribute to a strong collaboration and strong working relationship in Lifecycle Team and regulatory TA community, respectively.
• Subject matter expert (SME) within the department in defined area(s).