Specialist Regulatory Affairs - Nordic

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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?

We are looking for a Specialist Regulatory Affairs – Nordic. In this role, you will manage the regulatory lifecycle of a portfolio of marketed products across Nordic countries, ensuring that regulatory activities and submission plans are delivered on time and updated in response to changing requirements. You will work in Therapeutic Area team and with Regulatory Affairs colleagues in the Nordics and Europe to align priorities and deliver submissions.

You will serve as a subject matter expert for defined areas and maintain relationships with competent local regulatory health authorities across Nordic.

This role is based in Denmark.

How you will contribute:

• Perform lifecycle management activities including regulatory submissions, labeling updates, text reviews and launches using digital project management tools.

• Serve as the point of contact for assigned marketed products in the Nordic countries, supporting cross-functional partnership.

• Maintain relationships and communicate with regulatory health authorities across the Nordic countries.

• Act as a departmental subject matter expert for a defined area and provide guidance and support to teammates.

• Provide backup support for Nordic artwork activities and related regulatory requirements.

• Ensure compliance with applicable laws, policies, guidelines, and standard operating procedures including digital solutions where appropriate for compliance monitoring.

Skills and qualifications:

• Minimum one year of direct experience in regulatory affairs lifecycle management or equivalent regulatory experience; relevant academic degree preferred (Bachelor or master’s in pharmacy, life science, or related field).

• Understanding of regulatory requirements in the Nordic countries and the European Union.

• Experience working in a regional or matrix environment and collaborating with business units, supply chain, and medical affairs.

• Digital dexterity and familiarity with regulatory information systems, digital platforms, and an interest in artificial intelligence–driven processes.

• Strong written and spoken English; understanding or proficiency in other Nordic languages is an advantage.

• Clear communicator who collaborates effectively across teams and countries and builds productive working relationships with internal and external partners.

• Able to prioritize, make decisions within your remit, and remain focused under pressure, strong problem-solving skills.

• Willingness to learn, act on feedback, and develop skills; readiness to support change and adopt new digital ways of working.

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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