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Summary:
The Sr Manager, Regulatory Affairs – Drug Shortages supports regulatory decision-making related to supply interruptions. Serves as the primary liaison with FDA about Baxter products and its supply.
Essential Duties and Responsibilities:
- Liaising with FDA and provide Baxter product supply information for routine updates to CDER FDA Drug Shortage Website.
- Serve as primary Global Regulatory Affairs (GRA) interface with cross-functional teams.
- Propose/articulate technical/regulatory risk scenarios and mitigation plans.
- Leads or trains GRA colleagues and technical SMEs as needed.
- Review promotional material or SOP’s for compliance with local and global regulations.
- Monitor applicable regulatory requirements and address changes in regulatory landscape that may impact supply.
- Utilize internal regulatory intelligence capabilities and systematic tools to support or address supply situations.
- Effectively represent GRA in regulatory affairs data gathering, review, and recommendations.
Qualifications/Education:
- Proven negotiation skills as a regulatory strategist with drug shortage experience, broad technical experience, and strong interpersonal skills. Device experience is beneficial.
- Experience leading cross-functional teams to alleviate drug shortages, formulate responses to FDA queries, and partner effectively with FDA to secure approval of importation proposals.
- Ability to manage complex projects and timelines in a matrix team environment
- Ability to lead, coach, and motivate others
- Strong oral and written communication skills with senior-level management and project teams, while ensuring business objectives and deliverables are aligned with regulatory strategy.
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.
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.
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EEO is the law – Poster Supplement
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Reasonable Accommodations
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.
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