The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
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Our rapidly expanding team is seeking a Director ofRegulatory Affairs, Pharmaceutical Sciences to help lead the regulatory affairs department, and assist clinical operations, located in Guelph, ON. Working with the VP of Pharmaceutical Sciences, in a cross-functional project environment, the Director of Regulatory Affairs requires strong participation in the overall strategic planning and integration of new drug development within Nutrasource. The main responsibilities of the successful candidate will include (1) proposing or evaluating proposals from other senior company staff for strategies to maximize probability of regulatory approval of Nutrasource’s drug submissions in North America and global jurisdictions, balancing risks and timelines, and (2) working with the regulatory affairs team to support Nutrasource’s goals for submissions relating to new and existing drug products, maintenance of registrations nationally, and resolution of issues with regulatory agencies to expedite approval.
· Leads the design, planning and coordination of strategic divisional programs, key regulatory initiatives and submissions and related documentation to Health Canada, US FDA, and/or other regulatory Agencies, including CTA, DMF, IND, NDS, NDA, Medical Device applications, etc., ensuring compliance with the appropriate Act(s), Regulation(s), and Guideline(s);
· Ensures that applicable/appropriate regulatory affairs systems are in place to support efficient and effective submission of all regulatory filings, monitor the regulatory status of existing products, and minimize issues arising with regard to regulatory compliance in worldwide jurisdictions;
· Provides regulatory intelligence and assesses the regulatory acceptability and impact of scientific data and documents generated by Nutrasource. Alerts the project team in a timely manner of any significant findings for strategic planning, regulatory submissions, and impact for commercialization;
· Negotiates on behalf of Nutrasource with regulatory authorities, including formulating responses to questions and comments resulting from Agency review of submitted information;
· Ensures that project budgets, workplans and schedules are developed. Monitors, optimizes, and reports on adherence;
· Coordinates appropriate aspects of due diligence for drug candidate in licensing activities and of preparation of out-licensing packages. Recommends courses of action to senior management;
· Leads or contributes to broader activities relevant to the strategies, direction, and operations of Nutrasource, including strategic planning, process engineering, GXP inspection readiness, and others as required;
· Acts as departmental representative on multidisciplinary drug development projects and/or appoints appropriate regulatory affairs staff;
· Interface with Business Development, conducting due diligence and assessing commercial viability of potential drug and device products;
· Keeps abreast of domestic and global regulatory trends, laws, and movements;
· Advises and interacts with internal and external groups in areas of regulatory expertise;
· Maintains positive and cooperative communications and collaboration with all internal and external stakeholders;
· Maintains an attitude and philosophy consistent with the Company's standards
· Proficient knowledge of the North American regulatory framework for prescription and OTC drugs, biologics, and medical devices preferred;
· In-depth knowledge and experience in GXP and regulatory affairs principles, processes, and industry standards;
· Demonstrated application of negotiating and reasoning skills with first-tier regulatory agencies to achieve successful outcomes;
· Substantial experience of originating and directing regulatory submission strategies;
· Excellent oral and written communication, including the ability to interact effectively with both internal and external bodies;
· Experience and confidence in managing senior staff (peers and Executives) to meet common time and quality goals;
· Excellent attention to detail, and interpersonal, leadership, organizational, and (time) management skills;
· Capable of working efficiently within a complex multi-disciplinary environment;
· Solid problem-solving skills with an ability to identify solutions to problems under critical deadline constraints;
· Experience with using risk-based principles and decision making to ensure compliance at all stages of development;
· Strong negotiation skills, flexibility, and ability to provide a solution-based approach to emerging challenges;
· Computer literacy with MS Office Suite
· Master’s Degree in a scientific discipline or managerial and technical professional qualifications deemed to be equivalent;
· Minimum of 10 years industry experience, with at least 5 years of progressive leadership experience within the pharmaceutical regulatory affairs function of a CRO/Pharmaceutical/Medical Device company;
· Extensive knowledge of operations in North American and European regulatory environments, gained through formal and informal interaction with key regulators, as well as from detailed knowledge of relevant guidelines and policy documents
We thank all candidates for their applications, however, only those candidates selected for an interview will be contacted.
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Nutrasource brings the capabilities and scientific acumen of a global CRO while delivering the high-quality results you’d expect from your own team.
Our number one priority is you, the client. Everything we do—from offering flexible service packages to maintaining a diverse team suited to your project—is focused on providing you with the confidence to grow your business in an increasingly competitive market.
As your own virtual R&D department, we exist to tackle your toughest scientific problems and help you achieve your objectives. Whether your goals are straightforward and low-risk, or exceedingly complex with high stakes and a substantial investment on the line, we work in an integrated manner to offer you the highest possible quality and efficiency.
Nutrasource has humble roots and a big future. As our business expands, our promise remains the same: to help you support claims so you can grow your health products business through strong science and regulatory credibility.