Regulatory Affairs Manager, Nordics

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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 Danish LOC in Vallensbæk, we are looking for a Regulatory Affairs Manager, Nordics who will be responsible for life cycle management across all four countries.

• 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.

• Drive collaboration and strong working relationship in Lifecycle Team and TA community, respectively.

• Subject matter expert (SME) within the department in defined area(s),

ACCOUNTABILITIES

• Perform 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 and member of Cross Functional teams across Nordics.

• Engage in the TA communities actively driving collaboration and securing input and information sharing to enable adequate prioritization and resource planning.

• Establish and maintain relationship and line of 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.

• Engaging with EUCAN RA with regards to knowledge sharing and collaboration across the EUCAN RA/LOC network

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

• Academic degree (BSc/MSc) preferable in pharmacy or life science

• Previous experience in pharmaceutical industry/health authority in relation to life cycle management, preferably 3-4 years in regulatory affairs

• Basic understanding of regulations related to Regulatory Affairs across Nordics and EU

• Good communication skills, both written and orally.

• Fluent in English and Danish.

• Strong collaboration and stakeholder management skills

Empowering our people to shine

At Takeda, we earn the trust of society and our customers through our values of Takeda-ism: Integrity, Fairness, Honesty, Perseverance. We incorporate these values in everything we do. They represent who we are and how we act. They help us make decisions that we can be proud of today and in the future. We enable our employees to develop their full potential.

As a global top employer, we offer exciting career paths, promote innovation, and strive for top performance in everything we do. Takeda fosters an inclusive, collaborative, and international work environment where our teams are united by their relentless commitment to our goal of improving people's health and creating a better future for the world.

Diversity, Equality, and Inclusion

Takeda is committed to foster diversity, equality, and inclusion. Hiring decisions are based entirely on qualifications and are made regardless of gender, ethnic origin, religion, sexual orientation, age, or disability.

If you are interested in this opportunity, we look forward to receiving your application via our online tool!

Learn more at takedajobs.com

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