Nordic Regulatory Affairs Manager
Vallensbæk Strand, Capital RegionThe Europe & Canada (EUCAN) Business unit supports Takeda's mission at a regional level and as the leader in rare diseases and specialty care, we champion better health and a brighter future for patients, healthcare providers and our people.
Across the EUCAN BU, patients come first in every decision we make. We develop strategic partnerships which deliver value for society and create a culture within which our people can thrive and reach their full potential.
Our mission is to empower and enable our people to fulfill their potential by embracing diversity and creating a high-performance, collaborative working environment. In the EUCAN region integrity is one of our key values. We put patients, trust and reputation before business and this is one of the main reasons why our people choose to work here.
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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 Nordic Regulatory Affairs Manager who will work out of our Danish office in Vallensbæk.
You will join a Nordic team of 14 and 2 students, and we are based across the four Nordic countries. Over the last couple of years our team has strengthened the RA collaboration across the Nordics into a high performing, truly virtual collaborative team.
Strong collaborations and harmonization of our ways of working is what really drives us, as it gives us the opportunity to invest time and efforts into new projects and ideas as well.
In this role you will be working with the Nordics and collaborating with regional EUCAN Regulatory Affairs function.
OBJECTIVES/PURPOSE
Nordic product responsibility for regulatory lifecycle management of a product portfolio with the purpose to successfully deliver the EUCAN regulatory plans in alignment with agreed local business priorities.
Regulatory representative in local cross functional teams for assigned therapeutical areas (TA) across the Nordics
Drive collaboration by efficient coordination and strong working relationship our Lifecycle Team and TA community respectively.
ACCOUNTABILITIES
Responsible for 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 in the Nordics.
Establish and maintain relationship and communication with local competent regulatory health authorities in the Nordic countries.
Actively engage in cross functional and internal TA communities to support and secure adequate prioritization and resource planning.
Preparedness to engage with EUCAN RA with regards to knowledge sharing and collaboration across the EUCAN RA/Nordic network.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
Higher education degree (BSc/MSc) in pharmacy or life science.
Min 4 years of experience in pharmaceutical industry, and at least 3 years within local affiliate RA.
Full life cycle experience, including early access, maintenance and launches.
Expert knowledge in regulatory affairs regarding national and EU regulations and requirements.
Proven negotiation, influencing and delegation capabilities, based on excellent communication skills.
Demonstrated ability to work across functions, countries, and cultures independently; including ability to develop strong internal stakeholder management in a virtual environment.
Able to actively contribute to cross functional teams with in-depth and value-adding regulatory insights and expertise.
Fluent in Danish and English written and spoken - other Nordic languages are an advantage.
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
Locations
DNK - VallensbækWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeSuccess profile
What makes a successful team member within EUCAN at Takeda?
- Agile
- Analytical
- Enthusiastic
- Ambitious
- Collaborative
- Entrepreneurial
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Takeda named Global Top Employer for seventh consecutive year. Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
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About Takeda At Takeda, there is an unwavering commitment to putting patients first, and to creating a workplace that is underpinned by empowerment and focused on diversity, collaboration and steadfast values.
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Europe & Canada Business Unit Takeda in Europe and Canada (EUCAN) is delivering leading innovations in oncology, gastroenterology and rare diseases to provide better health and a brighter future for patients.
Working at Takeda
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Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team. -
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission. -
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. -
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024. -
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. -
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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