Regulatory Affairs Specialist

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.

You will be responsible for licensed pharmaceutical product portfolio(s), ensuring marketing authorisations are obtained and life cycle management activities are performed, in addition to some local CQA responsibilities, for products across the UK, Ireland and Malta.

• Support the managing and execution of regulatory strategies for assigned medicinal product portfolio(s).

• Provide guidance and oversee regulatory activities in support of timely submissions to regulatory agencies.

• Prepare, review and manage medicinal labelling documentation.

• Maintain awareness of regulatory requirements and ensure continued learning.

• Maintain product information databases and change controls.

• Participate as an active team member of project teams as required.

• Review promotional materials for compliance with local regulations.

• Provide Regulatory and Quality guidance to local management and business teams.

• Be responsible for CQA activities such as handling of Complaints and/or Field Actions.

• Management of Quality and Regulatory documents and procedures.

Qualifications.

• Knowledge of regulatory environment in UK & Ireland

• Scientific knowledge

• Project management skills

• Ability to work cross functionally and contribute to multiple projects

• Ability to multitask and prioritise

• Excellent interpersonal and communication skills

• Technical system skills (e.g. Veeva Vault, Microsoft Office, databases, online research)

Education and/or Experience.

• Bachelor’s degree or country equivalent in a relevant scientific discipline.

• Pharmaceutical Regulatory Affairs and/or Quality Assurance experience 2 - 5 years minimum, preferably within a UK healthcare environment.

Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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