Senior Specialist Regulatory Affairs - maternity cover

at  Baxter

THIS IS WHERE YOU SAVE AND SUSTAIN LIVES

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

SUMMARY

Join us on our journey to save and sustain lives in a strong experienced RA/CQA Nordic team.
Baxter is looking for someone with a few years of experience working in Regulatory Affairs and/or Quality Assurance covering during a 12-month maternity leave.
In this role you will work with both medical devices and pharma products.
You will ensure marketing authorizations and maintenance for pharmaceuticals and medical devices, manage local RA activities for the Nordic countries, support business product launches and tender application.
As a Senior RA specialist, you will work closely with other Nordic and Global RA leads and have an opportunity to participate in different projects to improve our RA and CQA working models in the Nordics, UK and Ireland.

QUALIFICATIONS

• Based in Sweden and familiar with the regulatory environment in all Nordic countries for pharma products and/or medical devices.
• Communicate fluently in Swedish and English internally and externally. Very good spoken and written English.
• Ability and experience to work cross functional with different functions involved: Global functions, QA, PV, tender etc.
• Project management skills
• Computer skills (Word, Excel, Power Point, Outlook, corporate software)
• Good interpersonal and communication skills

EDUCATION AND/OR EXPERIENCE

• University degree, preferably in pharmacy or natural sciences.
• Minimum 5 years of regulatory experience in pharmaceutical companies, familiar with the regulatory environment in all Nordic countries.
• Experience working as project leader in cross functional teams driving implementation of new processes.
• Understanding the EU Good Distribution Practice (GDP) requirements.
• Preferred: Experience with Medical Device and EU Medical Device Regulation.

• You are part of a strong experienced team in the Country Regulatory Affairs and Quality departments, and with support from Global functions.
• You will work closely with other Nordic and Global RA leads for managing and executing regulatory strategies for assigned product portfolio and Life Cycle Management Submissions for medicinal products.
• You will provide guidance and oversee regulatory activities in support of timely submissions to ensure there are no interruptions in supply.
• You are an affiliate member of the EMEA team and act as the Nordic regulatory stakeholder management expert.
• You assure regulatory compliance on applied, approved and/or marketed medicinal products and medical devices in Nordic countries.
• You will provide regulatory and quality guidance into local management and business teams (e.g., on launch activities, tender applications, significant product changes, marketing material).
• You will coordinate the handling of complaints and support in the management of quality documents.
• You need to have long experience in National Competent Authorities (NCA) communication in Sweden and other Nordic countries.
• You will maintain internal and external product information databases and change controls.
• You will oversee and manage the company’s labeling documentation by initiating, reviewing and approving Labelling Change requests.
• You will be part of the process for review and approval of marketing material together with medical and business teams.
• You will act professionally and efficiently to serve customers (internal and external) with high-quality information in a timely manner.
• You need to have strong self-leader and time efficiency skills.
• You will have an oversight and implement Field Corrective Actions for our medical devices in the Nordics.