Regulatory Affairs & QA Manager UKIE
Baxter · Reading
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Regulatory Affairs & QA Manager
UK, Ireland & Malta
We are looking for an experienced Country Quality Assurance (CQA) & Regulatory Affairs (RA) Manager to lead our Quality and Regulatory function across the UK, Ireland and Malta.
In this pivotal leadership role, you will be responsible for shaping and executing regulatory strategies that support our product portfolio while ensuring a robust and compliant Quality Management System (QMS) across the region. You will provide strategic direction, operational oversight, and expert guidance on quality and regulatory matters, working closely with cross-functional and global teams to support business objectives and maintain compliance with applicable regulations.
Reporting as a key leader within the organisation, you will also manage and develop the UK, Ireland and Malta CQA & RA team, driving a culture of quality, compliance and continuous improvement.
What You'll Be Doing
Regulatory Affairs
- Develop and execute regulatory strategies that support business goals, including new product launches and lifecycle management of marketed products.
- Lead regulatory activities for designated product portfolios, including pharmaceuticals and medical devices.
- Identify regulatory risks and implement effective mitigation plans.
- Monitor evolving regulatory requirements and ensure ongoing compliance with corporate policies and external regulations.
- Perform gap analyses of regulatory documentation and recommend practical solutions and improvements.
- Track regulatory submissions, approvals and documentation through effective internal systems and processes.
- Prepare, review and approve product labelling, promotional materials and Standard Operating Procedures (SOPs) to ensure compliance with local regulations.
- Build and maintain strong relationships with regulatory authorities.
- Collaborate closely with local marketing, commercial teams and global stakeholders to ensure regulatory deliverables align with business objectives.
- Provide expert regulatory guidance to cross-functional project teams.
Quality Assurance
- Lead the implementation, maintenance and continuous improvement of the local Quality Management System.
- Ensure compliance with Corporate Quality policies, EU GDP, EU GMP, ISO 9001, ISO 13485, MDR and other applicable local regulations.
- Monitor quality performance and regulatory compliance across distribution and commercialisation activities.
- Support internal and external inspections and audits, including responses to observations and tracking corrective actions.
- Develop and manage local self-inspection, training and customer eligibility programmes.
- Coordinate field actions, including recalls and safety notices.
- Support complaint handling processes, including the review of customer communications and investigation activities.
- Partner with Pharmacovigilance, Warehouse & Distribution, Technical Services and Commercial teams to maintain strong quality oversight.
Leadership & Stakeholder Management
- Lead, coach and develop the UK, Ireland and Malta CQA & RA team.
- Represent Quality and Regulatory Affairs within global, regional and cross-functional projects and initiatives.
- Drive collaboration across multiple functions in a matrix environment.
- Act as a trusted advisor to internal stakeholders on quality and regulatory matters.
- Represent the organisation in industry groups and external forums where appropriate.
What We're Looking For
- Strong scientific and technical knowledge within healthcare, pharmaceutical, medical device or related industries.
- Proven experience in Regulatory Affairs, Quality Assurance or a related discipline.
- Solid understanding of drug and medical device regulations and Good Distribution Practices (GDP).
- Demonstrated ability to manage complex projects and competing priorities.
- Strong leadership, influencing and stakeholder management skills.
- Excellent communication, presentation and negotiation abilities.
- Ability to work effectively within a multinational and multicultural environment.
- A proactive, solution-focused mindset with strong attention to detail.
Qualifications
Essential
- Bachelor's degree (or equivalent) in Pharmacy, Life Sciences or a related scientific discipline.
- Minimum 5-7 years of experience in Regulatory Affairs, Quality Assurance or a related field.
- Experience leading people, projects or cross-functional teams.
Desirable
- Master's degree and/or PhD in a relevant scientific discipline.
- Experience within a healthcare, pharmaceutical, medical device or CRO environment.
- Experience managing both pharmaceutical and medical device portfolios.
What are some of the benefits of working at Baxter?
- Competitive total compensation package
- Professional development opportunities
- High importance placed on work life balance
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Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Reasonable Accommodations
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