Sr Mgr, Regulatory Affairs-PMA Biologics
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.
Responsible and accountable for all operational aspects of regulatory submissions providing planning and technical support for Baxter’s products for one or more business units for the US region.
- This role will be supporting our Class III advanced surgical products (hemostats, bone fillers, etc). Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations
Initiate, manage and maintain operational activities in support of new and existing marketing authorizations
Plan and manage complex projects and prioritize workload
Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with Baxter and external standards
Maintain appropriate communication within the RA function, SBU marketing, and other functions primarily at the project team level
Communicate proactively and report to regulatory authorities
Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks
Set team, group, or service objectives to assure they align with the regulatory strategy
Provide technical and strategic input for regulatory decisions
Develop and document sound regulatory decisions and justifications
May manage budget at country level
May review promotional material or SOPs for compliance with local and global regulations
May provide direct supervision of individuals including mentoring, performance management and staffing decisions.
- Expert Regulatory knowledge
- Scientific Knowledge
- Ability to oversee multiple projects in a matrix team environment
- Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities
- Excellent oral and written communication and presentation skills
- Ability to accomplish results through others
- Ability to lead, coach, and motivate others
- Bachelor's degree or country equivalent in related scientific discipline with a minimum of 7 years experience in RA, including managing people or projects.
- Direct and substantial execution of PMA related submissions/FDA interactions
- Higher degree/PhD will be an advantage.
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 email to Corporate_Staffing_Deerfield@baxter.com or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.