Sr. Manager, Regulatory Affairs
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
Our Regulatory Affairs organization is transforming ourselves to be an adaptable, accountable workforce. Successful candidates will enjoy opportunities for professional growth and the flexibility to achieve a balance between work and personal life. Join us to make a difference and apply your skills in this unique role, where we aspire to disrupt current approaches to pharmacy compounding, taking it to a new level of control and customization for our patients.
Essential Duties and Responsibilities
- Define and execute regulatory strategies to support BaxPharma GBU drug compounding/manufacturing projects
- Represent or lead the RA function on assigned cross-functional project teams. Execute advice from expert consultants to deliver BaxPharma GBU plans. Lead and/or manage meetings with regulatory authorities, other functions and experts. Plan and manage complex projects and prioritize workload
- Monitor, evaluate, and interpret applicable regulatory requirements, assure compliance with Baxter and external standards
- Maintain communication within RA and other functions as needed
- Evaluate technical and scientific information, identify gaps or deficiencies, implement and execute strategies to remediate risks
- Develop and document sound regulatory decisions/plans and justifications
- Ensure regulatory strategy and deliverables are aligned with project teams and business objectives
Qualifications for this role
- US drug compounding (FDA 503A and 503B) regulatory and GMP experience. State Board of Pharmacy experience helpful.
- Experience with product, technology, and commercial aspects of drug compounding and manufacturing
- Global regulatory knowledge and experience in medical device registrations and compounding
- Ability to work independently and be a collaborative leader with relevant benchmarks and creative approaches.
- Ability to oversee multiple projects in a matrix team environment
- Demonstrated interpersonal and collaboration skills; proactively influences and negotiates to achieve strategic goals and objectives
- Excellent oral and written communication and presentation skills
- Ability to independently identify compliance risks and escalate when necessary
- Ability to lead, coach, and motivate others
Education and Experience
- Bachelor’s degree in related scientific discipline with a minimum of 7 years of experience in Regulatory Affairs, including managing people or projects.
- A licensed pharmacist/PharmD is preferred.
A Career That Matters
Baxter's employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
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.
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.