Local Regulatory - Canada

Syneos Health Careers • $90K — $110K *
US-AnywhereRemote in Ontario, CA
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 5-7 years of experience in regulatory submissions for biologics and small molecules in Canada.
  • Proven track record of Level III submissions and sNDS submissions.
  • Experience in coordinating annual drug notifications and PQRs.
  • Strong communication skills with direct interaction experience with Health Canada.
  • Self-sufficient in providing regulatory intelligence for local lifecycle management.

Responsibilities

  • Support client submissions to Health Canada for rare disease products.
  • Conduct Level III and sNDS submissions as part of lifecycle management.
  • Prepare and manage annual drug notifications and PQRs.
  • Coordinate responses to Health Canada through Clarifax.
  • Deliver local regulatory insights to support product submissions.

Benefits

  • Opportunities for professional growth in regulatory affairs.
  • Work in a collaborative environment with industry experts.
  • Chance to impact rare disease treatment through regulatory support.
Full Job Description
Description
Local Regulatory - Canada

Job Responsibilities

Candidate will be responsible for supporting client submissions to Health Canada for a Biologic / Small molecule rare disease product portfolio.

Experience of LCM submissions essential including:

- Level III Submissions

- sNDS Submissions

- PQRs

- Annual Drug Notifications

- Coordinating Clarifax responses

Experience of direct interaction with Health Canada is essential. Candidate must be able to provide local Canada regulatory intelligence and work self-sufficiently in supporting life cycle submissions in Canada.

CMC Biologic Authoring experience an advantage.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms.

Summary
Local Regulatory Expert for Canadian Lifecycle Maintenance Support

About Syneos Health Careers

Syneos Health Careers

Joining Syneos Health presents an unparalleled opportunity to become part of a global team of professionals dedicated to biopharmaceutical solutions. At Syneos Health, job opportunities abound, offering a gateway to enhancing career paths in a company celebrated for its commitment to therapeutic and operational excellence.

Work That Matters

Syneos Health is at the forefront of healthcare innovation, collaborating on projects that integrate smart technology and human ingenuity to improve patient outcomes. This dynamic company is actively seeking professionals who are eager to drive progress in the biopharmaceutical field through diverse job opportunities ranging from scientific roles to operational positions.

Innovative Employment Opportunities

Syneos Health offers a variety of positions that cater to a range of skills and experiences, from entry-level to senior leadership roles. Employment at Syneos Health means contributing to a culture that values diversity and inclusion, ensuring every team member’s voice is heard and valued.

Internship Programs and Professional Growth

For those starting their career, Syneos Health provides robust internship programs designed to foster professional growth and build essential industry skills. Interns at Syneos Health gain hands-on experience, beneficial for future employment opportunities within the company or the broader healthcare industry.

Cultivating Leadership and Professional Development

Syneos Health is committed to the professional development of its employees, offering leadership training and career growth opportunities that encourage innovation and leadership skills. Employees are supported through comprehensive benefits, diversity training, and initiatives that promote personal and professional growth.

Join a Team of Experts

The team at Syneos Health is composed of industry-leading experts who bring a wealth of knowledge and experience to the company. Networking within Syneos Health’s global community allows for unparalleled professional development and insights into the latest industry trends.

Explore Career Opportunities

Syneos Health is hiring! Explore the numerous positions available that match a variety of skills and interests. The company looks for driven, curious, and innovative team players ready to make a significant impact in the healthcare industry.

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Industry
Healthcare
* Ladders Estimates

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