Manager, Regulatory Affairs
Manager, Regulatory Affairs
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Job Description
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. Youll feel a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients.
Baxters 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 liveswhere your purpose accelerates our mission.
Job Summary
Youll be responsible and accountable for all global operational aspects of regulatory submissions providing planning and technical support for Baxters products for a business unit.
Instrumental on the design and definition of the Regulatory strategy for the products in the business unit. Conduct due diligence and support business development activities.
What youll be doing
- Develop and execute regulatory plans aligned with business strategy for complex projects including new products and maintenance of licenses/ authorizations for existing marketed products conducting due diligences and supporting business development activities
- Identify & prioritize key areas of risk and develop & implement appropriate mitigation plans
- Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
- Perform gap analysis on regulatory documentation and propose solutions. Identify areas for improvement
- Develop and document sound regulatory decisions and justification.
- Communicate with regulatory authorities
- Establish appropriate communication within RA with GBU Marketing and with other functions primarily at project level and favor proactive communication
- Ensure regulatory strategy and deliverables are aligned with project teams and business objectives
- Lead regulatory activities related to their portfolio of products
- May review SOPs for compliance with global regulations
- Represent or lead the RA function on assigned cross-functional project teams
- May represent Baxter interests in industry and working groups
- May provide direct supervision of individuals
What youll bring
- Bachelors degree or country equivalent in a scientific discipline
- Masters and/or PhD will be an advantage.
- Minimum of 12-years regulatory experience in RA or related field including managing people or projects.
- Scientific knowledge
- Ability to multitask and prioritize
- Ability to work effectively in multinational/multicultural environment
- Sound basis of Regulatory knowledge
- Management skills
- Ability to manage complex projects and timelines in a matrix team environment
- Strong interpersonal communication and presentation skills
- Demonstrated interpersonal skills including strong negotiation skills
- Technical and management skills
- Ability to lead and coach others
- Ability to independently identify compliance risks and escalate when necessary
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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Required Experience:
Manager
Employment Type
Full-Time
