Specialist, Regulatory Affairs

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.

Your Role:

In this role, you will be responsible for the local coordination and the preparation of documents/packages for regulatory submissions. You will be reviewing and evaluating technical and scientific data and reports required for local submission in support of Baxter’s products.  

Your Team:

We're a friendly, collaborative group of five who 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 do:

• Supports regulatory project plan execution

• Maintain awareness of regulatory requirements and ensure continued learning

• Maintain regulatory files in a format consistent with requirements

• Participate as an active team member of project teams as required

• Compile and prepare responses to questions from regulatory authorities according to plan

• Edit and proofread regulatory documentation

• Assist in preparation and review of labeling, SOP’s, and other departmental documents

• Compile under supervision regulatory documents for submission

• Track status and progress of regulatory documentation

• Prepare and review AdProm materials for compliance with local regulations

• Understand Regulatory Affairs' position in small project teams

• Provide input to Global and local RA strategies.  Assess potential risks and provide input for product development plans.  Review regulatory project plans/protocols and reports to meet Canadian regulatory requirements in collaboration with Global and local partners.

• Prepare high quality submissions including NDS, SNDS, Medical Device Licence Applications, CTAs, etc. according to current Health Canada requirements.  Collaborate with global and local teams to provide accurate responses to stakeholders within set deadlines.

• Assess proposed product, process and manufacturing site changes and execute necessary actions for implementation.  Support Third Party efforts.

• Support continuous improvement initiatives by actively participating on local and global cross-functional project teams ensuring milestones are met.  May be required to lead small projects (e.g. RFPs, JDE. SOPs).  Establish and/or improve local processes by reviewing, providing input and/or drafting departmental/cross-functional SOPs and Global procedures.

• In collaboration with Marketing, Medical Affairs and other business partners review and approve labeling and promotional material for regulatory compliance.  Compile materials required for Annual Drug / Device Notifications, Yearly Biologic Product Reviews and Site Licence Renewals.

• Participate in driving compliance with the quality system within regulatory affairs in assigned areas of responsibility.  Organize and maintain regulatory documentation in a format consistent with current RA practices and Baxter processes.  Administrative duties as assigned.

• Maintain awareness of current regulatory environment and guidelines that impact the Industry, the RA Department and Baxter.  Analyze, provide input into and compile comments for proposed regulations, guidance documents and policies.  Maintain close communication with both internal and external business partners and build solid advocate network to drive outcomes.

What you'll have

• 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

• Minimum 1 - 2 years Health Canada submission experience (includes NDS, SNDs, NC, DINA, CTA, Medical Device submissions (Class II-III)

• Knowledge of Canadian Food and Drugs Act and Regulations and Medical Device Regulations as well as Health Canada policies and guidelines

• Ability to interpret and apply Health Canada regulations, policies and guidelines

• Interpersonal and communication skills along with Negotiation skills

• Proficient computer skills including MS Office Applications

• Ability to work independently and self-motivated to achieve results

#LI-BAXGEN

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 [email protected] and let us know the nature of your request along with your contact information.

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