Regulatory Affairs ManagerReq # JR - 022640 Location Braine-l'Alleud, Wallonia, Belgium Job Category Regulatory Affairs Date posted 06/17/2020
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Responsible for independently defining global regulatory strategies and authoring eCTD submission content (EU / US) in support of new and existing marketing authorizations for pharmaceutical products for Renal Care drug products.
Essential duties and responsibilities
- Develop and execute regulatory plans and strategies for complex projects that impact existing drug product marketing authorizations globally.
- Author and coordinate submission content (eCTD M1-M5) for drug product marketing authorizations and variations / supplements to support dossier maintenance in EU / US.
- Perform regulatory impact assessments to determine reportability of proposed CMC and labeling changes on EU/US registrations.
- Develop and maintain drug product labeling content globally.
- Author submission content and deliverables in support of drug product registrations in the Americas, Asia Pacific, and Eastern Central Europe / Middle East / Africa.
- Provide RA functional leadership and participation on assigned cross-functional project teams and process improvement workstreams.
- Develop and document sound regulatory decisions and justifications
- Identify and prioritize key areas of risk and develop / implement mitigation plans.
- Establish appropriate, proactive communication within RA, with GBU Marketing, and other functions to ensure business objectives are consistently met.
- Communicate with regulatory authorities as required.
- Monitor, evaluate, and interpret applicable regulatory requirements; assure compliance with Baxter policies / procedures and external standards
- Bachelor’s degree or country equivalent in related scientific discipline. Master’s degree/PhD will be an advantage.
- Minimum of 5 years regulatory experience in RA or related field, including managing people or projects.
- Strong oral and written communication skills in English
- Lean Six Sigma / Green Belt certification will be valued.
- Direct, demonstrated experience in EU / US submission content authoring and preparing complex variations / supplements;
- Proven track-record of executing regulatory strategies with positive outcome and on-time approvals.
- Ability to manage complex projects and timelines in a matrixed team environment;
- Ability to work effectively in multinational / multicultural environment
- Strong oral and written communication skills and technical writing skills
- Sound basis of regulatory knowledge and strategic thinking
- Demonstrated interpersonal skills, including strong negotiation skills
- Ability to independently identify risks and escalate when necessary
- Demonstrated ability to lead and mentor others
- Scientific knowledge and previous work experience supporting aqueous pharmaceutical injections / solutions considered a plus.
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.