Global Regulatory Affairs SpecialistReq # JR - 023468 Location Guyancourt, Île-de-France Region, France Alternate Location : IT/ROM - Italy Rome Job Category Regulatory Affairs Date posted 06/22/2020
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Responsible for defining regulatory strategies and submissions for drugs and medical devices in support of new and existing marketing authorizations for Acute Therapies business unit /countries.
Essential Duties and Responsibilities
- Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations
- Represent or lead the RA function on assigned cross-functional project teams
- Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
- Establish appropriate communication within RA and other functions primarily at project level
- Perform gap analysis and propose solutions
- Develop and document sound regulatory decisions and justifications
- Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
- May provide direct supervision of individuals
- May review promotional material or SOP’s for compliance with local and global regulations
- Sound basis of Regulatory knowledge
- Scientific Knowledge (international Medical Device & Drugs regulations and international standards)
- Ability to manage complex projects and timelines in a matrix team environment
- Strong oral and written communication and presentation skills
- Demonstrated interpersonal skills including strong negotiation skills
- Ability to independently identify compliance risks and escalate when necessary
- Ability to lead and coach others
Education and/or Experience
- Bachelor’s degree or country equivalent in related scientific discipline with a minimum of 5 years’ regulatory experience in RA or related field, including managing people or projects. Higher degree/PhD will be an advantage.
- Experience in CMC, management of European procedures and/or FDA for new registrations as variations/renewals is strongly recommended
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.