Local Regulatory - Canada

Syneos Health Careers • $90K — $110K *
US-AnywhereRemote in Canada
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • 5+ years of experience in regulatory affairs, specifically in biologics or small molecules
  • Proven experience with Level III submissions and sNDS submissions
  • Familiarity with PQRs and Annual Drug Notifications
  • Strong understanding of interactions with Health Canada
  • Ability to provide local Canada regulatory intelligence
  • Experience in life cycle management submissions
  • CMC Biologic Authoring experience is a plus

Responsibilities

  • Support client submissions to Health Canada for rare disease products
  • Manage Level III submissions and sNDS submissions effectively
  • Prepare and submit PQRs and Annual Drug Notifications
  • Coordinate responses to Clarifax queries
  • Conduct local regulatory intelligence for Canada
  • Work independently on life cycle submissions
  • Author CMC documents for biologics if applicable

Benefits

  • Opportunity to work on impactful rare disease products
  • Gain experience interacting directly with Health Canada
  • Engage in independent project management
  • Access to professional development opportunities
  • Collaborative team environment focused on regulatory excellence
Full Job 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.

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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