Regulatory Affairs Specialist

7 days ago

Mississauga, Ontario, Canada BAXTER Full time
Job Description

At Baxter, we believe that our work improves outcomes for millions of patients. As a Senior Regulatory Affairs Associate, you will play a vital role in the local implementation of regulatory strategies and ensure compliance with Health Canada requirements.

About the Role

This is an exciting opportunity to join our team as a Senior Regulatory Affairs Associate. You will be responsible for preparing submissions, collaborating with stakeholders, and driving compliance with quality systems within Regulatory Affairs. You will also participate in the development and implementation of global and local regulatory strategies, negotiate with regulators, and evaluate risks to ensure effective issue resolution.

Responsibilities

- 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.
- Assist in coaching less experienced associates.
- 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.

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 (e.g., word processing, spreadsheets, databases, 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.
- Ability to identify compliance risks and escalate when necessary.

Benefits

Baxter offers a competitive salary range of $80,000 - $120,000 per year, depending on experience, plus benefits and opportunities for professional growth and development.

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