Regulatory Strategy Manager (Canada)

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

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