The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
The Principal Specialist is responsible for the development and implementation of complex global regulatory strategies for the Pharmaceutical GBU including; biosimilars, generics, 505(b)(2) and combination products. The person in this position will obtain and maintain marketing authorizations for US and EU (via CP, DCP, MRP, Worksharing, etc.) and will also provide oversight and support regulatory activities for Rest of World registration(s).
Essential Duties and Responsibilities
Initiate and develop complex regulatory project plans for New Product Development and Post-Market Variations
Identify & prioritize key areas of regulatory risk
Provide regulatory advice to project teams
Respond to complex questions from regulatory authorities within strict timelines
Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
Maintain and update existing regulatory authorizations
Manage regulatory activities relating to specific portfolio of products/projects
Prepare, review, and approve labeling and SOP’s
Lead or represent Regulatory Affairs in project teams
Provide guidance and coaching for areas of responsibility to lower level team members
Monitor applicable regulatory requirements
Create and maintain regulatory files in a format consistent with requirements
Knowledge of regulations with practical experience
Project management skills
Manage multiple projects and deadlines
Ability to multitask and prioritize
Interpersonal and communication skills
Strong negotiation skills
Technical system skills (e.g. word processing, spreadsheets, databases, online research)
Ability to work effectively in multinational/multicultural environment
Ability to identify compliance risks and escalate when necessary
Minimum of 5 years regulatory or equivalent experience within a pharmaceutical and/or medical device company, CRO, or similar organization
Experience with generics, biosimilars, EU Centralized registrations, Business Development, and Product Acquisitions will be an advantage
*We have a similar position in our Bloomington, IN facility*
Internal Number: 039599
About Baxter Healthcare
Every day, millions of patients and caregivers rely on Baxter’s leading portfolio of critical care, nutrition, renal, hospital and surgical products. You’ll find our products and therapies throughout hospitals and clinics—from the Emergency Room to the Operating Room, from the pharmacy to the Intensive Care Unit, ICU. We are also dedicated to advancing patients’ care in their homes.
We’re proud to serve communities in more than 100 countries. Together, we’ll draw upon our 90 years of experience as we transform healthcare. Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
Our Culture No matter your role at Baxter, your work makes a positive impact on people around the world.
At Baxter, we are deeply connected by our mission. Our work improves outcomes for millions of patients. You’ll feel an entrepreneurial spirit and sense of pride with anyone you talk with. Leaders provide the flexibility and autonomy needed to make your ideas a reality.
We lean on each other’s expertise to get work done. You’ll find it easy to build relationships here, as we share common traits like being reliable, ethical and caring. Together, we h...old each other accountable to Baxter’s values. This creates a place where we are happy, successful and take pride in our achievements. A place where you can do your best work.
Our fast-paced environment and forward momentum provides limitless professional opportunities. Baxter's resiliency and our diverse product portfolio reinforces our optimism for the future. Our position in the market inspires confidence throughout the organization.
Meaningful Career Experiences Our colleagues around the world are united by a passion for our mission to save and sustain lives. Finding meaning in our work is only part of how we provide impactful career experiences for our teams—we want our colleagues to do meaningful work as a part of a team they respect, in an environment that values each person’s contributions.
This is where your purpose accelerates our mission Your sense of purpose, and the talent you bring to the table, is exactly what accelerates our mission to save and sustain lives. At Baxter, each of us contributes our unique skills, experience and expertise—and we value differences as we lean on each other to get work done.
We are committed to nurturing an inclusive work environment in which every person feels appreciated, respected and safe to be their authentic self.