*About Baxter *
Every day, millions of patients and caregivers rely on Baxter’s leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on Twitter, LinkedIn and Facebook.
*Essential Duties and Responsibilities*
* Prepare submissions of increasing complexity, including NDS, SNDS, Medical Device Applications, CTAs, etc. according to current Health Canada requirements.Collaborate with key stakeholdersto 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 Licence 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.
* Administrative duties as assigned.
* University degree in Science, required.
* University degree in Science, MSc, preferred.
* Post-graduate Certificate in Regulatory Affairs, preferred.
*Major Subjects / Specialties*
* Sciences (e.g. Pharmacy, Chemistry, Biology, Pharmacology), required.
* Project Management, preferred.
*Type of Experience*
* Drug, biologic, device regulatory experience, Health Canada exposure
* Review of advertising and promotional materials.
* Strong technical knowledge of pharmaceutical manufacturing, quality assurance, GMP, ISO, ICH Guidelines.
* Regulatory Project Management
*Years of Experience*
* * 2 – 3 years Canadian Regulatory Experience, required.
* 4 – 6 years Canadian Regulatory Experience, preferred.
*Additional Skills / Special Training / Technical Skills*
* 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.
In addition to required skills:
* * Strong Project Management skills
* Strong negotiation skills
* Ability to lead, coach and motivate others
*A Career That Matters*
Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
Thank you for your interest and application to Baxter. All applications will be reviewed and those candidates selected for consideration will be contacted directly.
Baxter is committed to creating and maintaining a barrier-free environment for all employees and customers. We believe in integration and equal opportunity and we are committed to treating all people with dignity and respect.
**Job:** **Regulatory Affairs*
**Organization:** **Baxter Research & Development – Global RA – North America*
**Title:** *Senior Regulatory Affairs Associate*
**Requisition ID:** *190003N6*