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Pharmaceutical Product Specialist
2 months ago
Job Summary: We are seeking a highly skilled Technical and Scientific Advisor to join our team at Pharmascience. As a key member of our regulatory affairs team, you will be responsible for performing due diligence on existing innovator and generic product dossiers and providing technical assessment in terms of quality and acceptability to obtain approvals from health agencies.
Key Responsibilities:
- Perform due diligence on 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 perform gap analysis.
- Provide technical advice to resolve/mitigate identified gaps.
- Discuss technical risks associated with submission with internal team and agree mitigation plan.
- Actively participate in technical discussions with partners and explain the need for a mitigation plan to meet current expectations of regulatory guidance.
- Evaluate co-development projects (external) and review product development data by the partner and follow through to submission.
Requirements:
- Requires in-depth knowledge in understanding operating principles of analytical methods, specifications, formulation and processes to perform thorough gap analysis.
- Compliance with company policies and guidelines.
- Independent and thorough multi-disciplinary 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 while responding to new challenges.
- 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), given interactions with out-of-province partners and suppliers.
- Expertise in required business processes and technologies.
Preferred Qualifications:
- Excellent knowledge of the pharmaceutical industry and GLP/GMP regulations.
- Ability to work with various software tools, including Microsoft Office (Word, Excel), Microsoft Project.
- Innovative and inventive spirit.
- Team spirit and adaptability.
- Ability to manage stress and tight deadlines.
- 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.
