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

Syneos Health Careers • $100K — $120K *
US-Anywhere
+ 2 other locationsRemote
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 5-7 years of experience in CMC regulatory affairs, specifically with biologics and small molecules.
  • Proven experience with life cycle management (LCM) submissions.
  • Expertise in Level III submissions and sNDS submissions.
  • Strong background in authoring regulatory documents including local Module 3.
  • Direct interaction experience with Health Canada and ability to provide regional regulatory intelligence.

Responsibilities

  • Support client submissions to Health Canada for rare disease product portfolio.
  • Manage and execute Level III and sNDS submissions, ensuring compliance and accuracy.
  • Update local Module 3 documents and prepare PQRs.
  • Handle Annual Drug Notifications and coordinate responses to Clarifax requests.
  • Work independently on lifecycle submissions relevant to Canadian regulations.

Benefits

  • Remote work opportunity within Canada.
  • Engagement with a diverse portfolio of biologic and small molecule products.
  • Opportunity to support innovative drug development for rare diseases.
Full Job Description
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.

Summary
Local Regulatory CMC Support for a client portfolio in Canada.

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.

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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.

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Industry
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* Ladders Estimates

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