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
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.
#LI-Remote
Address
Related Content
-
March 05, 2024
-
Employee Benefits Our comprehensive benefits options reflect the value we place in our employees. March 28, 2024
-
People of Baxter The people of Baxter are men and women who make a difference at work and in their communities. March 28, 2024
-
March 05, 2024
-
March 05, 2024
-
How to Apply Learn tips to better prepare yourself for the application process. March 05, 2024 Related Content - SR_JD
-
March 05, 2024
-
March 05, 2024
-
June 14, 2024
-
June 14, 2024
-
June 05, 2024
-
May 07, 2024
-
Change Creates Opportunity We believe change provides the opportunity to push beyond what we thought we were capable of achieving. April 29, 2024
-
July 11, 2024
-
May 31, 2024
-
May 01, 2024
-
Meet Mike Hear from Mike Demirjian on how change is necessary for growth, innovation, and improvement. May 01, 2024
-
May 08, 2024
-
July 15, 2024
-
July 14, 2024
-
July 09, 2024
-
July 15, 2024
-
May 08, 2024
-
July 15, 2024
-
May 01, 2024
-
May 07, 2024
-
July 14, 2024
-
July 14, 2024
-
July 12, 2024
-
July 11, 2024
-
July 10, 2024
-
July 12, 2024
-
July 12, 2024
-
July 11, 2024
-
April 29, 2024
-
July 11, 2024
-
July 15, 2024
-
July 14, 2024
-
July 13, 2024
-
July 13, 2024
-
July 13, 2024
-
July 09, 2024
-
July 10, 2024
-
July 09, 2024
-
Our Proposed Separation We plan to separate our Kidney Care Global Business Segment from Baxter to become a separate company. Discover what this means for you. May 03, 2024 Related Content - SR_JD
-
May 23, 2024
-
July 11, 2024
-
Meet Yukinari Yukinari Kono believes a leader should instill confidence and optimism in his teams during times of transformation. May 08, 2024
-
Career Areas Explore our various career sectors and uncover the one that aligns best with your talents and professional goals. March 05, 2024 Related Content - SR_JD
Join Our Talent Community
We're grateful for your interest in a career with Baxter, and would like to get to know you. Joining our Talent Community is a great way to stay connected, learn more about Baxter, and help our recruiters find you if there's an opportunity that aligns with your background, skills and interests.