Sr Manager, Regulatory Affairs (Remote)

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. 

Your Role at Baxter
Drive regulatory strategy and deliverables regarding company core data sheets (CCDS) and respective Regulatory systems, for therapeutic and combination products. Manage the initialdevelopment, approval and ongoing complianceof therapeuticand combination product labeling content throughoutthe product life cycle. Lead cross-functional teams to manageCCDS/labelcontent, standardize, and enable best practices across all businesses.

What you'll be doing

• Lead creation and maintenance of Company Core Data Sheets (CCDS)/Company Core Safety Information (CCSI) activities in support of new and existing marketing authorizations.
• Drive global implementation of CCDS into country-specific labeling and provide strategic labeling recommendations.
• Participate in the execution of regulatory labeling and content strategies for new products and ongoing compliance for products already on market.
• Formulate and drive global technology, process and solution initiatives to standardize, and enable best practice in labeling and content management.
• Provide technical and strategic input for regulatory decisions aligned with business strategy.
• Identify & prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans and follow ups.
• Provide technical and strategic input for role-based regulatory decisions aligned with business needs.
• Monitor, evaluate, and interpret applicable regulatory requirements, assure compliance with Baxter and external standards.
• Assess impact of new regulations and provide feedback.
• Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks.
• Act as a contact for meetings with regulatory authorities including planning and leadership.
• Maintain appropriate communication within the RA function and with other functions.
• Planandmanagecomplexprojects andprioritizeworkload.
• Initiate, manage and maintain role-based operational activities.
• RepresentBaxterinterestsinindustryandworkinggroups.
• Set team, group, or service objectives to assure they align with the regulatory strategy.
• Providedirectsupervision ofindividuals includingmentoring,performance management and staffing decisions.

What you'll bring

• Bachelor's degree or country equivalent in a scientific discipline. Masters and/or PhD will be an advantage.
• Minimum of 7-year experience in RA, including managing people or projects and at least 2 years of CCDS experience.
• Ability to work effectively in multinational/multicultural environment
• Management skills
• Technical and management skills
• Expert Regulatory knowledge
• Sound basis of Scientific (Training/Communications) knowledge
• Ability to oversee multiple projects in a matrix team environment
• Excellent oral and written communication and presentation skills
• Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities
• Ability to lead, coach, and motivate others
• Ability to accomplish results through others
  

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $136,000 - $187,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

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.

EEO is the Law 
EEO is the law - Poster Supplement
Pay Transparency Policy

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

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