Project Leader, CMC Regulatory Affairs

PUB336402

About this role: Project Leader, CMC Regulatory Affairs

About this role: Project Leader, CMC Regulatory Affairs

The Project Leader CMC assumes senior responsibilities to ensure the completeness of CMC documentation for all product dossiers and timely market approvals. He/she will also take part in the evaluation of new opportunities and other cross-functional projects. The ideal candidate is highly organized with a desire and ability for continuous learning, has excellent communication skills and quickly adapts to changing priorities. The Project Leader is considered as a departmental ambassador that fosters collaboration with all stakeholders and leads discussions with Health Authorities.

  • Plan, manage, execute and coordinate the preparation, compilation, filing, and approval of high-quality regulatory submissions for presentation to the relevant Health Authorities for new products and to maintain as well the compliance and life cycle of currently marketed products.
  • Takes the lead on complex regulatory files and projects and has the ability to engage project teams collaboratively.
  • Critical assessment of data and documents to identify gaps compared to regulatory requirements and develop mitigation strategies for execution with project teams.
  • Prepare and review of responses to Health Authority requests and Deficiency Letters in timely manner and lead the negotiations with Health Authorities to ensure prompt regulatory approvals of dossiers under review and in preparation.
  • Interact, communicate, and negotiate with internal and external stakeholders.
  • Complete regulatory impact assessment of quality/GMP change control requests.
  • Maintain current awareness of all regulatory guidelines and understand the impact on the department’s processes.

Requirements

Requirements

  • Minimum 5 years regulatory work experience.
  • Ability to interpret and apply regulatory requirements to highly complex projects.
  • Ability to provide feedback to Health Authorities and concerned internal stakeholders on new emerging regulatory trends and requirements to minimize negative impacts to the company.
  • Excellent working knowledge, drug development, manufacturing, and commercialization of regulated healthcare products (drug products, natural health products, and medical devices if applicable).
  • Highly advanced organizational and communication skills (oral and written).
  • Ability to prioritize projects, coordinate multiple projects simultaneously and work with tight deadlines in a collaborative manner.
  • Bilingual (English and French).
  • Computer literacy: Microsoft Word, Excel, and Outlook, Adobe Acrobat.

Benefits

Benefits

Why apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We managethe process for you: from submitting your resume to coordinating interviews to extending offers and
assisting with on-boarding. We’ll get you going while you get on with the job

Join the Brunel Family

Join the Brunel Family

Brunel has a reputation for working with some of the best in the business. That’s what we continually strivefor. Over 45 years, we’ve created a global network of interesting clients and talented individuals working
together through a vast array of services

Start applying immediately

Start applying immediately

Sending an application is quick and easy. Just make sure you have the required documents ready to go.

  • Certifications (optional)
  • Job references (optional)
  • Motivation Letter (optional)
  • Resume or up-to-date LinkedIn / Xing profile
Apply now

Any questions remaining?

Your consultant, Michael Leung is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB336402

Account manager

Michael Leung
Brunel Canada - Toronto
m.leung@brunel.net

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