Regulatory Strategy Manager (Canada) at Vertex Strategies Inc

Toronto, Ontario, Canada -

Full Time

Start Date

Immediate

Expiry Date

07 Aug, 26

Salary

166000.0

Posted On

09 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Canadian Regulatory Requirements, Health Canada Regulations, Regulatory Strategy Development, Regulatory Communications, Promotional Review, Regulatory Application Management, Drug Development, Clinical Trial Design, Clinical Pharmacology, Regulatory Intelligence, Cross-functional Collaboration, Problem Solving, Technical Writing, Project Management, Scientific Analysis, Compliance Monitoring

Industry

Software Development

Description

Job Description General Summary: The Regulatory Strategy Manager will be responsible for regulatory support for development programs or marketed products. The Regulatory Strategy Manager will contribute to the development of Canadian regulatory strategies for development and commercialization of products within the portfolio. This role requires a strong understanding of Canadian regulatory requirements, excellent communication skills, and the ability to collaborate cross-functionally to achieve business objectives. Key Duties and Responsibilities: Contributes to the development and implementation of regulatory strategy as a member of the Canadian regulatory affairs team within the Global Regulatory Affairs organization Responsible for regulatory communications with Health Canada; under supervision, may lead regulatory interactions with the health authority Review and approve promotional and non-promotional items, including training material, in accordance with local regulatory requirements Identifies regulatory requirements for development and approval pathways for Canada Manages the process for preparation, submission, and approval of regulatory applications to Health Canada Provides technical regulatory input for key product development or registration documents Provides regulatory guidance and support to cross-functional teams to ensure regulatory compliance throughout the product lifecycle Reviews regulatory intelligence and guidance information to continuously support regulatory strategy in Canada Knowledge and Skills: Strong knowledge of Canadian regulatory requirements, including Health Canada regulations, guidelines and submission processes. Strong organizational skills and attention to detail, with the ability to manage multiple projects simultaneously. Understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacology Ability to assess and understand complex scientific information, regulatory precedent, competitive intelligence, and regulatory guidelines Strong problem-solving skills Strong written and verbal communication skills to exchange complex information with others in complex situations Ability to work effectively within a team environment Education and Experience: Bachelor's degree in Biology, Chemistry, or other related discipline Minimum 3 years of experience in regulatory affairs within the pharmaceutical industry, with a focus on Canada Pay Range: CAD 145,000 - CAD 166,000 The compensation range provided reflects a reasonable estimate of the total target cash compensation (base salary and annual bonus) for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with applicable legal requirements. Actual compensation will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, retirement and so much more. This recruitment process may involve the use of artificial intelligence (AI) to assist in screening and assessing applications. AI may be used at various stages to support decision-making, including reviewing resumes and evaluating qualifications. If you have any questions about how AI is used in this process, please contact ApplicationAssistance@vrtx.com. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.

Responsibilities

The Regulatory Strategy Manager develops and implements Canadian regulatory strategies for the development and commercialization of products. This includes managing communications with Health Canada and reviewing promotional materials for compliance.