Manager, Regulatory Affairs (Injectables)

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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.

Job Summary

You’ll be responsible and accountable for all global operational aspects of regulatory submissions providing planning and technical support for Baxter’s 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 you'll 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 SOP’s 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 you'll bring

Bachelor’s degree or country equivalent in a scientific discipline
Master’s 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.

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Manager, Regulatory Affairs (Injectables)

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