Regulatory Affairs Lead

1 week ago

Oakville, Ontario, Canada AmerisourceBergen Full time
About the Role

We are seeking an experienced Regulatory Affairs professional to lead our team in developing and implementing regulatory strategies for pharmaceutical, biologic, and medical device development. The successful candidate will have a proven track record of managing multiple projects simultaneously, prioritizing tasks, and meeting deadlines.

Key Responsibilities
  • Prioritize and manage multiple simultaneous projects to meet budget, timelines, and client expectations;
  • Responsible for development and implementation of RA activities including assessments, strategies, submissions, and agency interactions, applying expert knowledge in core areas of regulatory practice (e.g., CMC, Medical Devices, CTAs, US, etc.);
  • Create opportunities to build agency relationships by participating in professional activities such as offering industry training, conference presentations, publications, and webinars;
  • 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;
  • Proactively identifies, shares, and interprets regulatory intelligence;
  • Manage multiple simultaneous projects to ensure they are on budget, meet timelines, and client expectations;
  • Engage in continuous learning activities 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;
  • Advanced Degree in a related field is preferred;
  • 12+ years of relevant experience in regulatory affairs or related functions in pharmaceutical/biologic/medical device development/manufacturing. Medical devices, clinical trials, CMC may be required;
  • Regulatory Affairs Certification (RAC) and other certifications are an asset;
  • Prior consulting experience is preferred;
Requirements
  • 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 within established timelines in a dynamic environment;
  • Advanced strategic planning and complex problem-solving skills to resolve complex issues with innovative solutions effectively and efficiently;
  • Demonstrated senior leadership abilities in a cross-functional, multi-disciplinary team environment;
  • Ability to communicate effectively both orally and in writing;
  • Knowledge of computers, to operate effectively with Adobe Acrobat, Microsoft Word, Excel spreadsheets, and Microsoft Outlook; Ability to develop professional networks that will drive business development and regulatory intelligence;
What We Offer

We offer a comprehensive compensation package, including a salary range of $133,200 CAD - $205,260 per year, based on experience and qualifications. In addition to competitive pay, we also provide benefits, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and more.

Affiliated Companies:

Affiliated Companies: Innomar Strategies

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