Regulatory Affairs Specialist

3 weeks ago

Mississauga, Ontario, Canada BAXTER Full time
Key Responsibilities:

- Prepare and submit regulatory documents, including NDS, SNDS, Medical Device Applications, and CTAs, according to current Health Canada requirements.

- Collaborate with stakeholders to provide accurate and timely responses to Health Canada, identifying priorities and key issues in complex situations and achieving resolution with minimal assistance.

- Participate 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.

- Assess proposed product, process, and manufacturing site changes according to Health Canada regulations and initiate necessary actions to facilitate implementation, supporting third-party efforts.

- Compile materials required for Annual Drug/Device Notifications, Yearly Biologic Product Reviews, and Site License Renewals.

- Develop, review, and/or approve labeling in collaboration with marketing, providing guidance to Marketing, Medical Affairs, and other business partners on initiation or modification of labeling and promotional material ensuring regulatory compliance.

- Assist in coaching less experienced associates and lead, provide 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.

- Evaluate and identify risks, providing contingency planning to ensure effective issue resolution, and 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, and 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, 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.

Requirements:

- 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.

- Knowledge of regulations and compliance requirements, scientific knowledge, and technical skills, including word processing, spreadsheets, databases, and online research.

- Strong project management skills and ability to manage multiple projects and deadlines, ability to multitask and prioritize effectively, excellent interpersonal and communication skills, including negotiation abilities, and ability to identify compliance risks and escalate when necessary.

About Baxter:

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.

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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