Regulatory Compliance Specialist

3 weeks ago

Mississauga, Ontario, Canada BAXTER Full time

About Baxter:
Baxter is a leading medical technology company committed to improving healthcare outcomes for patients worldwide. With a rich history of innovation, we have pioneered significant medical advancements that transform healthcare.



Job Description:
Senior Regulatory Affairs Associate plays a pivotal role in shaping our regulatory strategies, ensuring compliance with Health Canada regulations, and driving the successful launch of our products. This dynamic role requires a highly motivated individual with a strong background in regulatory affairs and excellent communication skills.



Key Responsibilities:
As a Senior Regulatory Affairs Associate, you will be responsible for the local implementation of regulatory strategies, obtaining and maintaining marketing authorizations for products, and communicating local regulatory requirements to support the licensing of Baxter's products. Your role will also involve supporting regulatory activities related to specific products and projects, ensuring compliance with Health Canada regulations.



Responsibilities include:
• Preparing submissions of increasing complexity, including NDS, SNDS, Medical Device Applications, and CTAs, in accordance with current Health Canada requirements.
• Collaborating with key stakeholders to provide accurate and timely responses to Health Canada, identifying priorities and key issues in complex situations, and achieving resolution with minimal assistance.
• Participating in driving compliance with the quality system within Regulatory Affairs, organizing and maintaining regulatory documents in a format consistent with current RA practices and Baxter processes.
• Assessing proposed product, process, and manufacturing site changes according to Health Canada regulations and initiating necessary actions to facilitate implementation, supporting third-party efforts.
• Compiling materials required for Annual Drug/Device Notifications, Yearly Biologic Product Reviews, and Site License Renewals.
• In collaboration with marketing, developing, reviewing, and/or approving labeling, providing guidance to Marketing, Medical Affairs, and other business partners on the initiation or modification of labeling and promotional material, ensuring regulatory compliance.
• Assisting in coaching less experienced associates.
• Leading and providing guidance in the development and implementation of global and local regulatory strategies, negotiating with regulators on specific projects relating to data requirements to ensure success.
• Evaluating and identifying risks, providing contingency planning to ensure effective issue resolution.
• Developing and/or reviewing regulatory project plans/protocols and reports to meet Canadian regulatory requirements.
• Leading, identifying, and driving continuous improvement initiatives by actively participating on local and global cross-functional project teams, ensuring milestones are met. Establishing and/or improving local processes by reviewing, providing input, and/or drafting complex departmental/cross-functional SOPs and Global procedures.
• Maintaining awareness of current regulatory environment and guidelines that impact the Industry, the RA Department, and Baxter, analyzing, interpreting, assessing impact, providing input into, and compiling comments for proposed regulations, guidance documents, and policies.
• Maintaining close communication with both internal and external business partners and fostering positive relationships.
• Administrative duties as assigned.



Requirements:
This role requires a Bachelor's degree or country equivalent in a scientific discipline and a minimum of 2 years of regulatory or equivalent experience within a pharmaceutical and/or medical device company, CRO, or similar organization. You should have knowledge of regulations and compliance requirements, scientific knowledge and technical skills, strong project management skills, and the ability to multitask and prioritize effectively. Excellent interpersonal and communication skills, including negotiation abilities, are also essential.



Salary:
The estimated salary for this role is $85,000 - $110,000 per year, depending on location and experience.

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