Canada, Canada
Experience: 4-6 Years
Education Level: Professional Bachelor
Life Sciences
Closing: August 07, 2025

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Introduction

We are currently hiring a Director or Regulatory to join a leading global pharmaceutical solutions organization dedicated to improving lives. Their services range from drug discovery support to lifecycle management, which helps empower pharmaceutical and biopharma companies of all sizes to realize the full potential of their products.

What are you going to do 

  • Responsible for preparing client proposals and generating new business, including leading presentations to potential RA clients, and participating in multifunctional presentations
  • Prioritize and manage multiple simultaneous projects to meet budget (including invoice review), timelines and client expectations; anticipate and resolve emerging issues
  • Responsible for development and implementation of RA activities including assessments, strategies, submissions and agency interactions, applying expert knowledge in core area of regulatory practice (e.g., CMC, Medical Devices, CTAs, US etc.) and at least basic knowledge outside of core area
  • Maintain target billables by obtaining new business
  • Creates opportunities to build agency relationships by participating in professional activities such as offering industry training, conference presentations, publications and webinars
  • Leads client and agency interface, with responsibility for strengthening relationships and growing the business. Responsible for the quality of deliverables, by ensuring compliance with the company and client review and approval processes; identifies and implements opportunities for process improvement
  • Develop and maintain partnerships with senior decision-makers to build the business, resolve significant issues, and create opportunities
  • Analyze data, the regulatory environment and business objectives to make and implement recommendations, using judgement to identify innovative solutions while managing uncertainty.
  • Lead and advise clients and cross-functional teams on agency interactions Leads decision-making and conflict resolution surrounding regulatory issues within cross-functional teams
  • Proactively identifies, shares and interprets regulatory intelligence
  • Manage multiple simultaneous projects to ensure that they are on budget, meet timelines and client expectations.
  • Engages in continuous learning activities in order to provide effective consulting services and be a sought-after resource.
  • Develop and manage 0-2 regulatory direct reports at Manager level or below, as assigned including but not limited to assignment delegation, time and budget management, skill and knowledge development

Essential skills and knowledge 

  • BSc. degree in life sciences (Pharmacology, Molecular Biology, Biology, Chemistry or Pharmacy) or Engineering.
  • Advanced Degree in related field is preferred
  • 12+ years of relevant experience in regulatory affairs or related functions in pharmaceutical/biologic/medical device development/manufacturing. In-depth experience in a designated area of specialization (e.g. Medical devices, clinical trials, CMC) may be required
  • Prior consulting experience is preferred.
  • Broad understanding of international regulations, processes and issues in drug/biologics/medical device development. Includes sound knowledge of ICH, Health Canada, FDA, EMA, and other relevant guidelines with focus in area of specialization such as CMC, biologics, pharmaceuticals, Clinical Trials, OTC/NHPs medical devices, or FDA.
  • In depth experience of successfully managing Health Authorities interactions on a regional basis
  • In depth regulatory expertise in the area of regulatory specialization required for the role, such as medical devices, CMC, or advertising/promotion
  • Extensive experience and working knowledge of a wide range of regulatory submission types.
  • Superior project management skills to manage multiple concurrent projects in a dynamic environment
  • Advanced strategic planning and complex problem-solving skills to resolve complex issues

What we offer 

What We Offer

Why apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. We'll get you going while you get on with the job.

About Us

Brunel has a reputation for working with some of the best in the business. That's what we continually strive for. Over 45 years, we've created a global network of interesting clients and talented individuals working together through a vast array of services.

Are you the perfect match for this vacancy? Apply in 5 minutes and let's get in touch!

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Anything Else?

Shape your future

Are you ready for the next step in your career? Join Brunel’s powerful global network, where passionate, results-driven specialists come together with industry-leading clients. By connecting specialists to pioneering projects, we drive change in many industries, enabling growth and delivering great outcomes. Brunel helps you reach your full potential and empowers you to make an impact within a purpose-driven global company.

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Our Culture and Values

At Brunel, we are proud of our unique corporate culture, which is shaped and nurtured by the collective efforts of our employees. Our work environment is characterised by an authentic, communicative and inclusive approach to teamwork that fosters an atmosphere of collaboration and creativity. Our values are at the center of everything we do – for our clients, our colleagues and ourselves.

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Our ESG Commitment

Since 1975, our mission has always been to connect specialists to exciting career opportunities, to support the development of these careers, and to offer fair and equal employment. This has enabled us to create a truly sustainable and durable business model. Having a passion for people and caring deeply for the environment is not only part of Brunel’s DNA but is also reflected in our culture and values. As a global company, we take our social responsibility very seriously.

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Do you have any questions about this vacancy ? 

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Sarah Beaton

+1 403 539 5009