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.

Our team is recruiting and for this we need bright minds with creativity and flexibility – what talent do you have?

For our Regulatory Affairs team, we are looking for a new Regulatory Affairs Manager who will join our Nordic team. Regulatory Affairs Nordics is a team of 14 based across Denmark, Norway, Sweden, and Finland. The preferred location for this position is in Stockholm.

“This role offers you the entire life cycle responsibility for the product portfolio from affiliate perspective, bridging our commercial business to the local regulatory environment in the Nordic countries. Regulatory Affairs is working in close partnership with the commercial business units and our European regulatory colleagues, and we are an important contributor in ensuring that we get the medicines to the patient safely and in compliance with EU and local laws and regulations,” explains your new manager Associate Director, Regulatory Affairs, Mette Bjersing

OBJECTIVES and KEY HIGHLIGHTS

• Local project lead for launches and lifecycle management for an assigned product portfolio to successfully deliver regulatory activities with agreed business priorities.
  
  
• Cross functional team member and local point of contact for the product portfolio.
  
  

ACCOUNTABILITIES

• Management of lifecycle activities and launches of new products and new indications across the Nordics.
  
  
• Responsible for evaluation and submission of regulatory applications, updates, and local launches in defined product portfolio.
  
  
• Establishing and maintaining relationship and communication with local competent regulatory health authorities across the Nordic countries.
  
  
• Commit to regulatory compliance with relevant legal governance, code of conduct, guidelines, and applicable SOPs to ensure inspection-readiness in accordance with local regulations and internal processes.
  
  

EDUCATION, KNOWLEDGE & EXPERIENCE AND SKILLS

• Master’s degree in Pharmacy or life science.
  
  
• Minimum 4 years of experience from the pharmaceutical industry of which at least 3 years are from regulatory affairs area preferably from an affiliate perspective.
  
  
• Full life cycle experience, including early access, maintenance and launches.
  
  
• Expert knowledge in regulatory affairs regarding national EU regulations and requirements.
  
  
• Fluent in spoken and written English and preferably also in Swedish.
  
  

You will be joining a lean team, where our ability to collaborate, communicate and leverage on each other’s knowledge make us a valuable partner for the organization as serving our patients the best way.

You are driven by curiosity and supports our regulatory Vision and Mission, and you will take ownership of your own continuous development in agreement with your line manager.

“If you are looking for a role that offers you self-leadership, and trust in working independently and at the same time releases empowerment and a positive team spirit, this is the right place for you. For me our openness and transparency are crucial. We actively contribute by asking questions, delivering in-depth and value-adding regulatory insights, and embracing new ideas. I welcome you who comes with a solid regulatory understanding, and who can strengthen our partnerships across the organization as well as our team spirit internally” ends Mette.

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

SWE - Stockholm - LindhagensgatanDNK - Denmark Remote, FIN - Remote, NOR - Asker RemoteEmployeeRegularFull time