Senior Specialist CMC, Global Regulatory Affairs

2 weeks ago

Montréal QC, Canada Pharmascience Full time

Description :

The Senior Specialist CMC assumes 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 good communication skills and adapts to changing priorities.

Tasks & Responsibilities:

  • Plan, manage, and execute 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..
  • Critical assessment of data and documents to identify gaps compared to regulatory requirements and develop mitigation strategies for discussion with project teams.
  • Prepare and review of responses to Health Authority requests and Deficiency Letters in timely manner and actively participate in 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.
Skills, Knowledge and Abilities:
  • 3 to 5 years regulatory work experience.
  • Ability to interpret and apply regulatory requirements to moderately complex projects.
  • Advanced working knowledge, drug development, manufacturing, and commercialization of regulated healthcare products (drug products, natural health products, and medical devices if applicable).
  • 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.
  • Business Acumen to actively contributes to the department’s key performance indicators
  • Drive Results: Consistently achieve results even under tough circumstances.
  • Optimize Work Processes: Understands departmental and key corporate processes and efficiently performs tasks as per documented processes with a focus on continuous improvement.
  • Ability to effectively build formal and informal relationship networks inside the organization
  • Good communication skills
Education : Bachelor

Experience : 3 years: Experience in Regulatory Affairs #J-18808-Ljbffr

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