Regulatory Affairs Manager Estonia (fixed term 18- months)
Tallinn, Harju Job ID R0185371 Category Regulatory Affairs Subcategory Research & Development Business Unit Research & Development Job Type Full timeBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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?
About the Role
At Takeda, we are committed to improving health and creating a better future for patients worldwide. As Regulatory Affairs Manager for Estonia, you will play a key role in ensuring our medicines remain compliant, available, and accessible to patients. Acting as the local regulatory expert, you will work closely with regional and global teams, health authorities, and external stakeholders to support product lifecycle management, new product launches, and regulatory excellence across the Estonian market.
This is an exciting opportunity to make a direct impact on patient access while joining a collaborative, purpose-driven organisation that values innovation, integrity, and continuous improvement.
This is a 18-months contract.
How You Will Contribute
Serve as the local Regulatory Affairs Responsible for Estonia.
Lead and coordinate regulatory submissions, including new marketing authorisations, variations, and renewals.
Manage communications and relationships with local and global health authorities.
Ensure compliance with applicable regulatory requirements, legislation, and industry guidelines.
Oversee product lifecycle activities, including maintenance of regulatory databases and implementation of regulatory changes.
Manage updates to product information, labelling, artwork, and packaging materials.
Provide regulatory expertise to support product launches and business initiatives.
Monitor regulatory developments and advise stakeholders on potential business impacts.
Coordinate regulatory notifications, including product shortages, recalls, defects, and safety communications in collaboration with Quality teams.
Support inspections and audits and maintain regulatory inspection readiness.
Represent Takeda within relevant industry associations and external regulatory forums.
Act as the local NMVO contact person.
Provide backup support for product complaint management when required.
Drive effective implementation and continuous improvement of local regulatory processes
What You Bring to Takeda
Bachelor's degree or higher in Pharmacy, Life Sciences, Biotechnology, Chemistry, Biology, Medicine, or a related scientific discipline.
Approximately 3-5+ years of experience in Regulatory Affairs within the pharmaceutical or healthcare industry.
Strong knowledge of EU pharmaceutical regulations and local regulatory requirements.
Experience managing regulatory submissions and product lifecycle activities.
Ability to work effectively in a matrix environment with cross-functional and international stakeholders.
Excellent communication, stakeholder management, and collaboration skills.
Strong organisational and project management capabilities, with the ability to manage multiple priorities.
Proven problem-solving and decision-making skills with a proactive and independent approach.
Fluency in Estonian and English.
Commitment to the highest ethical and compliance standards.
Ability to travel occasionally within the region and across Europe as required.
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
Tallinn, EstoniaBase Salary Range:
€34,600.00 - €47,520.00For information about our benefits, please click here.
