Regulatory Affairs Manager (Company Core Data Sheets)

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.

The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes.

This person is instrumental in the design, development, and maintenance of global Regulatory processes and business solutions. This is an important individual contributor who will partner with key business, functional and business stakeholders to ensure commercial objectives are achieved.

Essential Duties and Responsibilities

• Lead creation and maintenance of Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI) for assigned drug/therapeutic/pharmaceutical products
• Manage the change and facilitate tracking through to implementation the CCDS content into global and country-specific labeling
• Lead global CCDS change committees.
• Provide strategic input to internal partners and manage feedback from global stakeholders on labeling issues.
• Plan and manage complex projects
• Represent or lead the RA function on assigned cross-functional project teams
• Monitor, evaluate, and interpret all new and existing applicable regulatory requirements related to assigned product portfolio labeling
• Assess and communicate impact of new regulations
• Align CCDS team objectives with global regulatory and business objectives
• Deliver inputs in response to Quality initiatives or audit and regulatory authority questions associated with responsibilities
• Identify & prioritize key areas of risk, and develop & implement appropriate mitigation plans
• May represent Baxter interests in industry and working groups
• May provide direct supervision of individuals
• Perform gap analysis on regulatory documentation and propose solutions. Identify areas for improvement
• Develop and document sound regulatory decisions and justification

Qualifications

• Scientific knowledge
• Ability to multitask and prioritize
• Ability to work effectively in multinational/multicultural environment
• Sound basis of Regulatory knowledge, including drugs/biologics/pharm/therapeutics
• Management skills
• Ability to manage complex projects and timelines in a matrix team environment
• Strong interpersonal, communication and presentation skills
• Demonstrated interpersonal skills including strong negotiation skills
• Technical and management skills
• Ability to lead and coach others
• Ability to independently identify compliance risks and escalate when necessary

Education

• Bachelor’s degree or country equivalent in a scientific discipline, pharmacy, biochemistry or similar preferred
• Masters, MD and/or PhD will be an advantage

Experience

• Minimum of 5 years of regulatory experience in RA or related field, including managing people or projects
• Minimum 2 years of creating and/or managing CCDS/CCSI/RSI

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.