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Headquartered in Montreal, Canada, Knight Therapeutics is a fast-growing specialty pharmaceutical company for Canada and select international markets.
Knight Therapeutics Inc. is a pan-American (ex-US) specialty pharmaceutical company focused on acquiring, in licensing, out-licensing, marketing, and commercializing innovative prescription pharmaceuticals in Canada and Latin America. Headquartered in Montreal, Knight has operations in Canada and in 10 countries in Latin America and has over 700 employees globally.
Reporting to the Director of Regulatory Affairs, the RA Associate Director (Clinical expertise) will assume global responsibilities within the Regulatory Affairs department to contribute to the assessment of new business partnerships/acquisitions as well as opportunities arising from the current portfolio, to leverage medical and clinical evidence. This position covers Canada and LatAm, in collaboration with corporate partners. The ideal candidate is highly organized, has flexible and adaptable communications capabilities, demonstrate good problem-solving skills and can adapt to changing priorities.
This is a full-time position for a Montreal-based candidate.
The candidate must have good analytical skills with high-level attention to detail and commitment to accuracy and depth.
The candidate must have good interpersonal skills and demonstrate flexible and adaptable communications capabilities with partners inside and outside the country, as well as with regulatory authorities. She/He must have the ability to motivate, lead, and grow a regulatory affairs team.
She/he must be able to effectively function in a fast-paced, people oriented, team environment where priorities may shift. She/he will be able to handle multiple projects at a time.
The candidate must work independently yet interact with various people. She/he must have the ability to identify important issues and identify solutions in a timely manner.
The candidate must demonstrate adaptability in situations involving constant changes and an ability to evaluate and properly adapt the documents supplied by corporate partners for Canadian regulatory requirements.
Required | Asset | |
| Education: | · Advanced scientific degree (i.e. MSc, PharmD, PhD, MD) or · MD, PharmD, PhD, MS in life science /or an equivalent combination of education or experience | · M.Sc. in drug development |
| Experience: | · Strong scientific knowledge · Strong knowledge of the Canadian regulations and international regulations (LATAM regions), good ability to interpret policies and guidelines. · Excellent communication skills, written and oral in English is mandatory; French proficiency is an asset | · 7-10 years within the pharmaceutical industry, including managerial responsibilities. · Knowledge of international regulations · Spanish or Portuguese (written and oral) |
| Other: | · Good knowledge of Microsoft Office Suite | · Project management tools |
Send your resume to: careers@knighttx.com
Company & Location Knight Therapeutics Inc. located in Canada
Senior Analyst – Pharmaceutical Development PMO
Education: Higher Education in Pharmacy, Engineering or Administration
English: Advanced, speaking, reading and writing.
Desirable: PMP Certification
Experience: Minimum of 3 years of experience as PMP, good manufacturing practices for pharmaceuticals, risk assessment tools, qualification/ validation protocols, knowledge of change management in formulation or packaging.
Position: Remote
Assist in planning and executing projects, meeting budget, scope and schedule requirements. Help ensure consistent practices across all phases of the project life cycle. Execute high-quality, integrated cross-functional plans for projects. Apply best practices in project development, initiation, planning, execution, control, and closeout. Interact with R&D, Marketing, Manufacturing, Regulatory Affairs and Quality departments as well as external partners.
Good understanding of the pharmaceutical development process, including regulatory and quality related aspects, excellent verbal and written communication skills, ability to manage multiple unique assignments simultaneously.
Day-to-day management of the development, planning and execution aspects of projects, including internal and partner branded generics development projects, product integration and transition, and launch readiness.
Sets goals and objectives for cross-functional team members to achieve operational results.
Coordinates activities across functions and teams, ensuring good cross-functional communication and project execution.
Challenges internal staff and partners to optimize project execution.
Proactively identifies concerns, provides solutions and offers alternatives.
Creates status reports for management, ensuring compliance with regulatory agencies, managing schedules, assessing project risks, specifying project plans, and establishing work schedules.
Send your resume to: careers@knighttx.com
