Base Career helps you apply smarter for this job.
Key skills for this role
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.
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.
Skip the repetitive application forms
Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.
Trusted by over 500,000 job seekers on Base Career
More from this employer
Ahmedabad, IND
Bengaluru, IND
Bengaluru, IND
Thetford, GBR
Ahmedabad, IND
Bengaluru, IND
Ahmedabad, IND
Bengaluru, IND
Bengaluru, IND
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.
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.
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.
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.
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.
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 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.
Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice .
Global medical products and healthcare technology company.
Visit company websiteJobs and hiring trendsFull-time
Senior · 5+ years experience
Onsite
Apply faster on company sites with our extension.