Senior Regulatory Affairs SpecialistReq # JR - 068587 Location Mississauga, Ontario, Canada Job Category Regulatory Affairs Date posted 05/05/2022
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.
As Senior Regulatory Affairs Specialist you will be responsible for development of RA strategies and execution of regulatory submissions to Health Canada. The incumbent will ensure compliance of post-approval activities as per the Health Canada Food and Drugs Act and Regulations.
- Prepare submissions of increasing complexity, including NDS, SNDS, Medical Device Applications, CTAs, etc. according to current Health Canada requirements.
- Collaborate with key stakeholders to provide accurate and timely responses to Health Canada.
- Identify priorities and key issues in complex situations and achieve resolution with minimal assistance.
- Participate in driving compliance with the quality system within Regulatory Affairs.
- Organize and maintain regulatory documents in a format consistent with current RA practices and Baxter processes.
- Assess proposed product, process and manufacturing site changes according to Health Canada regulations and initiate necessary actions to facilitate implementation. Support third party efforts.
- Compile materials required for Annual Drug / Device Notifications, Yearly Biologic Product Reviews and Site License Renewals. - In collaboration with marketing, develop, review and/or approve labeling. Provide guidance to Marketing, Medical Affairs and other business partners on initiation or modification of labeling and promotional material ensuring regulatory compliance.
- Lead and provide guidance in the development and implementation of global and local regulatory strategies. Negotiate with regulators on specific projects relating to data requirements to ensure success.
- Evaluate and identify risks, and provide contingency planning to ensure effective issue resolution.
- Develop and/or review regulatory project plans/protocols and reports to meet Canadian regulatory requirements.
- Lead, identify and drive continuous improvement initiatives by actively participating on local and global cross-functional project teams ensuring milestones are met. Establish and/or improve local processes by reviewing, providing input and/or drafting complex departmental/cross-functional SOPs and Global procedures.
- Maintain awareness of current regulatory environment and guidelines that impact the Industry, the RA Department and Baxter. Analyze, interpret, assess impact, provide input into and compile comments for proposed regulations, guidance documents and policies.
- Maintain close communication with both internal and external business partners and foster positive relationships.
- Education Level - University degree in Science
- Post-graduate Certificate in Regulatory Affairs
- 2 - 3 years Canadian Regulatory Experience
- Drug, biologic, device regulatory experience, Health Canada exposure Preferred: - Review of advertising and promotional materials.
- Strong technical knowledge of pharmaceutical manufacturing, quality assurance, GMP, ISO, ICH Guidelines.
- Regulatory Project Management
- Good written and verbal communication skills. - Ability to work in a fast-paced dynamic environment
- Excellent time management skills and a sense of urgency.
- Strong organization skills and ability to prioritize work load.
- Accuracy and attention to details.
- Excellent interpersonal and collaboration skills.
- Ability to work independently and self-motivated to achieve results.
- Proficient computer skills including MS Office Applications
- Strong negotiation skills
- Ability to lead, coach and motivate others
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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Mississauga, ON L5N0C2
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