Careers at Knight Therapeutics

We are committed to positively impacting people’s health and quality of life. We are growing rapidly because of our people, whose talent, character and initiative make Knight an employer of choice.

Diversity

At Knight, we value multiple individual perspectives and are committed to hiring and retaining people from diverse backgrounds, ethnicities, religions and experiences.

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Career Opportunities

Headquartered in Montreal, Canada, Knight Therapeutics is a fast-growing specialty pharmaceutical company for Canada and select international markets.

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Position Summary


Reporting to the Director of Regulatory Affairs, the Regulatory Affairs Senior Manager will assume responsibilities within the Regulatory Affairs department to ensure the timely approval and regulatory maintenance of pharmaceutical products in Canada, in collaboration with corporate partners. The ideal candidate is highly organised, 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.


Specific Responsibilities

  1. Develop and implement regulatory strategies aligned with business objectives to support the registration, approval, and commercialization of pharmaceutical products in Canada.

  2. Oversee the preparation, review, and submission of regulatory documents, including pre-submission meetings, new drug applications (NDAs), supplemental applications, variations, and annual reports, ensuring accuracy, completeness, and compliance with regulatory requirements.

  3. Build regulatory timelines to support the company business plans. Develop strategic goals with staff, and provide guidance as needed for completion of tasks. Maintain effective communication with partners and project team members. Report progress, challenges, issues, actions and support required.

  4. Manage the regulatory aspects of the product portfolio throughout its lifecycle, including post-marketing activities such as variations, notifications, labelling updates, and lifecycle management strategies.

  5. Elaborate internal processes for the development of the Regulatory Affairs’ department in collaboration with other Knight departments.

  6. Laise with Health Canada for general regulatory matters and product specific issues, including meetings with the Agency.

  7. Lead and mentor a team of regulatory professionals, providing guidance, coaching, and support to ensure high performance and professional development. Maintain ongoing training to ensure the team’s competence in regulatory matters.

  8. Stay abreast of industry trends, competitive landscape, and emerging regulatory requirements. Provide strategic advice to senior management on regulatory issues that may impact the company.

  9. Contribute to the development of business strategies considering the regulatory environment.

  10. Identify regulatory risks and opportunities, assess potential impact, and develop risk mitigation strategies to minimize regulatory challenges and optimize product approvals and lifecycle management.

  11. Effectively communicate internal and external regulatory requirements within the organization.


Characteristics of a Good Candidate

  1. Analytical and Organisational Skills

The candidate must have good analytical skills with high-level attention to detail and commitment to accuracy and depth.

  1. Negotiation skills / Teamwork

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.

  1. Ability to Multitask

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. 

  1. Autonomy / Problem Solving

The candidate must work independently, yet interacting with various people. She/he must have the ability to identify important issues and identify solutions in a timely manner.   

  1. Dealing with Ambiguity

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.


Candidate Profile

 

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 good ability to interpret policies and guidelines.

·  Excellent communication skills, written and oral in English and French

·     5 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

As illustrated in the description of the tasks, it requires, in particular, to communicate, verbally and in writing, with the other team members located across Canada as well as Latin America as well as customers across Canada. Following an assessment, we have therefore determined that the performance of these tasks requires the knowledge of the English language, in addition to the knowledge of the French language (written and spoken). We have also determined that the English knowledge already required from other employees is insufficient for the performance of the duties requiring the knowledge of English.

Send your resume to: careers@knighttx.com

Description:

 

Reporting to the Associate Director, Business Development, the Sr. Analyst, Business Development is a key member of the business development team, playing a significant role in deal sourcing, market analysis, scientific assessment and financial valuation. The ideal candidate is highly inquisitive with a keen desire and ability for continuous learning. The candidate should have a strong business and financial background as well an ability to understand scientific and clinical data. In addition, the candidate should have great communication and organizational skills as well as an ability to adapt to changing priorities and to manage ambiguity.

 

Key Responsibilities:

  • Support identifying and triaging of new business development opportunities.
  • Analyze market data, identify trends & opportunities, and provide actionable insights.
  • Complete all activities related to new product assessments including the review of scientific literature and clinical data as well as the performance of qualitative market research with key opinion leaders.
  • Collaborate with cross-functional teams to identify risks, opportunities, and gather key inputs for financial models.
  • Perform financial analysis and valuation, and support deal structuring.
  • Stay updated on industry regulations, market dynamics, and emerging trends in the pharmaceutical market.
  • Prepare presentations summarizing product assessments and valuations to senior management.

 

Essential Skills & Requirements:

 

  • Bachelor/Master’s or Graduate degree in business, finance, or science(s). A dual background in business/finance and science is preferred.”
  • A minimum of 2 years of work experience in a business development, equity research, consulting, or clinical development.
  • Strong analytical and quantitative skills, including good understanding of financial valuation concepts (NPV, IRR, DCF, etc.)
  • Ability to work with large datasets.
  • Broad understanding of the biotech/pharmaceutical industry
  • Ability to understand scientific concepts and clinical data.
  • Excellent time management skills as well as the ability to prioritize among multiple projects.
  • Great communication skills, both written and oral.
  • Self-starter and results-oriented: able to determine approach required to identify trends and draw appropriate conclusions.

 

Assets:

 

  • Experience in reviewing and interpreting financial statements.
  • Demonstrated ability to influence decisions that have broad business impact.

About Knight

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.

Position Summary

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.

Specific Responsibilities

  • Contributing to the analysis of potential agreements from the medical-clinical perspective regarding the product in question, understanding the strengths and weaknesses of non-clinical and clinical studies from the viewpoint of health authorities.
  • Assessing any necessary complimentary studies for registration in the case of incremental innovative products.
  • Evaluating the feasibility of registering potential new indications based on ongoing studies.
  • Preparing scientific position papers, briefing books, and supporting pre-submission meetings related to medical-clinical information to be presented to the health authorities.
  • Contributing to the analysis of available literature to enhance product indications.
  • Interpretation of bioequivalence results.
  • Comprehending, from the perspective of access and price regulation, the opportunities concerning products in the portfolio.
  • Proposing new opportunities to enhance the product monograph from a regulatory perspective, considering treatment lines, combined therapies, and local standard of care.
  • Providing clear directives to achieve a balance between regulatory concerns, marketing objectives, compliance, time to market, and costs.

Characteristics of a Good Candidate

  • Analytical and Organisational Skills

The candidate must have good analytical skills with high-level attention to detail and commitment to accuracy and depth.

  • Negotiation skills / Teamwork

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.

  • Ability to Multitask

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.

  • Autonomy / Problem Solving

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.

  • Dealing with Ambiguity

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.

 

Candidate Profile

 

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

Characteristics and Skills:

 

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.

Role and Responsibilities:

 

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

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