CMC Regulatory Consultant (Biologics Must Have) - Canada Remote Based

Syneos Health Careers • $100K — $120K *
US-AnywhereRemote in Canada
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 5-7 years of regulatory experience in biologics or small molecules
  • Proven track record with Life Cycle Management (LCM) submissions
  • Hands-on experience with Level III and sNDS submissions
  • Strong knowledge of Health Canada submission processes
  • Local expertise in regulatory intelligence for Canada
  • Excellent skills in CMC (Chemistry, Manufacturing, and Controls) authoring

Responsibilities

  • Support client submissions to Health Canada for rare disease products
  • Manage Level III and sNDS submissions effectively
  • Update local Module 3 documents as required
  • Prepare and submit Annual Drug Notifications
  • Coordinate responses to Clarifax queries
  • Provide regulatory intelligence specific to Canadian market
  • Work independently on life cycle submissions in Canada

Benefits

  • Fully remote position offering flexibility
  • Opportunity to work with rare disease product portfolios
  • Engagement in high-impact regulatory processes
  • Collaboration with Health Canada
  • Possibility for growth and cross-functional interactions
Full Job Description
CMC Regulatory Consultant (Biologics Must Have) - Canada Remote Based

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, including updating local Module 3 documents

- PQRs

- Annual Drug Notifications

- Coordinating Clarifax responses

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

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.

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.

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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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* Ladders Estimates

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