Scientific and Technical Advisor

3 days ago


Candiac, Quebec, Canada Pharmascience Full time
Job Title: Scientific and Technical Advisor

The Scientific and Technical Advisor plays a crucial role in ensuring the quality and acceptability of pharmaceutical products. As a key member of the team, you will be responsible for performing due diligence on existing product dossiers and providing technical assessments to obtain approvals from health agencies.

Key Responsibilities:
  • Conduct thorough gap analysis of licensing project dossiers for solid oral and/or sterile injectable and other specialty dosage forms.
  • Review and compile dossier information submitted in other jurisdictions and identify areas for improvement.
  • Provide technical advice to resolve/mitigate identified gaps and ensure compliance with regulatory guidelines.
  • Collaborate with internal teams to discuss technical risks associated with submission and agree on mitigation plans.
  • Engage in technical discussions with partners and explain the need for mitigation plans to meet current regulatory expectations.
Requirements:
  • Requires in-depth knowledge of analytical methods, specifications, formulation, and processes to perform thorough gap analysis.
  • Compliance with company policies and guidelines.
  • Independent and thorough multidisciplinary and leadership skills.
  • Open-minded and collaborative with the ability to interact tactfully and discreetly.
  • Agile and organized with the ability to manage changing priorities under tight deadlines.
  • Excellent communicator with the ability to integrate easily into diverse teams.
  • Ability to convey new ideas and approaches in a positive manner.
  • Knowledge of and ability to work effectively in both French and English (written and spoken).
  • Expertise in required business processes and technologies.
Preferred Qualifications:
  • Holder of a doctorate in pharmacy.
  • 8 years' industrial experience or Master's degree in pharmacy/life sciences with 10 years' industrial experience in various dosage forms.

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