REGULATORY AFFAIRS MANAGER

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 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.
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