AstraZeneca is one of the world’s most exciting bio-pharmaceutical companies. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that improve patients’ lives and benefit society. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. More information about AstraZeneca on www.astrazeneca.com

AstraZeneca Central Eastern Europe – Baltic marketing company is a fast paced and evolving organization focused on excellence in science, brands and people. Representing 11 countries, we have offices in Budapest, Bucharest, Prague, Warsaw, Belgrade, Sofia, Zagreb, Ljubljana, Riga, Tallinn, Vilnius.

The role

As a Regulatory Affairs Manager you will be responsible for all aspects of regulatory work for defined part of the products. Additionally you will cover the sign-off process mainly in Estonia, including activities, materials and relevant non promotional material from a market ethical point of view compliant with rules, regulation, practice and internal policies.

The role is full time and based at our office in Tallinn, Estonia.

Accountabilities:

• Regulatory lifecycle management and regulatory expertise and support across the organization
• Communicate with Health Authorities on pending issues and changes in regulatory requirements; drive and develop key AstraZeneca specific regulatory questions and processes
• Support activities related to product labelling and packaging material
• Ensure that the marketing company follow ethical standards in all activities and materiel, including develop processes and conduct training and coaching of relevant employees.
• Accountable for the ethical interaction process, sign-off process, champion the EFPIA transparency process and market ethics complaint handling process
• Working closely with the local internal colleagues, the region and local cross-functional team to give input to relevant strategies and deliver against agreed targets.
• Pharmacovigilance back-up person in the Baltic countries handling complaints and recalls
• Contribute to the development of an effective team in the Baltic organization
• Contribute to continuous improvements within the function to develop and simplify business

Essential requirements:

• University degree in Pharmacy or equivalent
• Demonstrate experience with Regulatory and work
• Can communicate fluently in English and Estonian
• Good knowledge of relevant legislation requirements and procedures
• Foster culture of innovation and collaboration
• Ensure personal competence development

You will have a great opportunity to develop professionally as well as personally and will be a part of a working environment with collaborative organizational culture, on-the-job training and development opportunities, competitive salary and bonus schemes as well as other benefits.

More information

For more information about the position please contact hiring manager Baiba Bergmane, baiba.bergmane@astrazeneca.com.

Welcome with your application!

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AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.