Senior Specialist, Regulatory Affairs (12 Months Contract)
ID de la oferta JR - 127615 Ubicación Mississauga, Ontario, Canadá Categoría de Trabajo Administrative Fecha de publicación 04/24/2024This 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.
Your role at Baxter
This is where your expertise lead to success
As aSenior Specialist, Regulatory Affairsyou will be implementing local regulatory strategies, acquire and maintain marketing authorizations for product(s) and communication of local regulatory requirements in support of licensing of Baxter’s products.
We're a friendly, collaborative group that help each other to constantly push each other to do better.
We understand that learning and development are important. Whether it's training, striving toward a promotion, or gaining experience with other portfolios or business units, Baxter leaders frequently speak with their teams about how employees are trying to grow and how they can support those efforts. With the ability to chart your own path, the development opportunities are endless.
What you'll be doing
With direction, develop and execute regulatory project plans
Identify and elevate key areas of regulatory risk
Maintain regulatory files in a format consistent with requirements
Maintain awareness of regulatory requirements; identify relevant requirements
Participate as an active team member and provide regulatory advice to project teams as required
Respond to questions from regulatory authorities within strict timelines
Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
Maintain and update existing regulatory authorizations
Support regulatory activities relating to specific portfolio of products/projects
Prepare, review, and approve labeling and review AdProm materials for compliance with local regulations
Prepare SOPs to reflect specific local requirements.
Represent or lead Regulatory Affairs in small project teams
What you'll bring
Bachelor’s degree or country equivalent in a scientific discipline
Minimum of 2 years regulatory or equivalent experience within a pharmaceutical and/or medical device company, CRO, or similar organization
Strong project management skills
Ability to lead multiple projects and priorities
Interpersonal and communication skills along with Negotiation skills
Hands on technical expertise (e.g. word processing, spreadsheets, databases, online research)
Ability to identify compliance risks and escalate when necessary
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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
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
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