Senior Specialist, Clinical Regulatory Affairs

Job Description

Senior Specialist, Clinical Regulatory Affairs

The Senior Specialist, Clinical Regulatory Affairs is responsible for all clinical submission requirements for their assigned product portfolio. They serve as the regulatory point of contact for local stakeholders and Global Regulatory Affairs, and collaborate effectively with other colleagues in Clinical Regulatory Affairs and CMC. The Senior Specialist is also expected to take on additional activities, including projects and leading team initiatives.

Key Activities and Responsibilities:

• Project Management: Lead regulatory projects related to federal submissions (i.e., NDS, SNDS, etc.) for an assigned list of products.

• Preparation of regulatory submissions and follow-up with Health Canada until a final regulatory decision is reached. This includes interactions with Health Canada and acting as the primary contact with this agency regarding submissions.

• Ensure that all activities related to the registration of new products and their maintenance on the Canadian market comply with the Food and Drugs Act and its regulations, all relevant Canadian guidelines, and company policies.

• Manage Health Canada requests (safety signal assessment, requests for information, Access to Information [ATI] requests, etc.) as a priority and within prescribed timelines, ensuring they are immediately assessed and communicated to management and global teams.

• Manage updates to safety labels, filings for PSURs (Periodic Safety Update Reports), and RMPs (Risk Management Plans) in accordance with local and global procedures.

• Ensure the filing and maintenance of CTA (Clinical Trial Application) submissions with Health Canada, in collaboration with clinical research colleagues and in compliance with local and global procedures.

• Perform tasks in a manner fully consistent with the company's commitment to its Code of Conduct, values and standards, policies, procedures, industry standards, and all laws and regulations. This includes the obligation to report all Adverse Events (AEs) and Product Quality Complaints (PQCs) in accordance with company policy, the "Know to Report" pharmacovigilance training, and Health Canada regulations.

Skills:

• Perform other activities as requested by the Director or Associate Director, Clinical.

• Hold a university degree (B.Sc. or higher) in health sciences or the equivalent.

• Demonstrate excellent communication and time management skills, as well as the ability to work independently with minimal supervision.

• Possess a minimum of 5 years of proven experience and success in the field of regulatory affairs.

Functional Competencies:

• Awareness of the Health Canada Food and Drugs Act and its regulations, and the ability to interpret them.

• Knowledge of regulatory affairs science, concepts, and terminology.

• Knowledge of local operating procedures.

• Understanding of the company's Global Regulatory Affairs organization, its processes, and compliance expectations.

• In-depth understanding and ability to interpret Health Canada regulatory requirements and guidance documents that impact clinical submissions.

Communication Skills

• Fluency in French is required.

• Ability to communicate effectively verbally and in writing.

• Knowledge of Good Documentation Practices (GDocP).

Computer Skills

• Excellent skills in using word processing, presentation, and spreadsheet applications.

• Proficiency in using large-scale compliance databases.

• Ability to quickly familiarize oneself with new computer interfaces.

Personal Qualities

• Excellent time management, organizational, and planning skills.

• Rigor, precision, and a high level of attention to the quality of work.

• Strong collaboration and teamwork skills.

• Compliance-oriented (compliance mindset).

• Courage and candor.

This job posting is for an existing vacancy.

The anticipated base salary range for this position is $98,560 - $147,840 CAD. At our company, we are firmly committed to providing fair compensation for comparable work and experience, which is a fundamental element of our organizational culture. Individual employee compensation is determined based on several factors, including relevant experience, skills and level of proficiency, as well as other legitimate factors related to appropriate internal comparators.

We put people at the heart of our priorities. This position is eligible for our discretionary short-term incentive program, which fosters a pay-for-performance culture. Furthermore, our total rewards and benefits programs go beyond traditional plans (medical and retirement) to create a flexible and inclusive workplace that supports the well-being, development, and long-term success of our employees.

We may use artificial intelligence and automated tools to support our recruitment process. These tools are used to support, not replace, human judgment. All hiring decisions are made by our hiring managers.

We are proud to be a company that values the contribution of diverse, talented, and committed individuals. The fastest way to foster innovation is to bring together diverse ideas in an inclusive environment. We encourage our colleagues to respectfully challenge each other's perspectives and solve problems collectively. We are an equal opportunity employer and are committed to fostering an inclusive and diverse workplace.

We encourage applications from all qualified individuals. In accordance with our accommodation policies and applicable provincial and federal accessibility legislation, we are committed to providing reasonable accommodations throughout the recruitment process.

Required Skills:

Adaptability, Audits Compliance, Detail-Oriented, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Project Management, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations, Regulatory Strategy Development, Regulatory Submissions

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

Senior Specialist Clinical, Regulatory Affairs

Responsible for all Clinical submission requirements for their assigned product portfolio. The Senior Specialist is the Regulatory contact with local stakeholders and Global Regulatory Affairs and effectively collaborates with the other Regulatory Clinical and CMC colleagues. The Senior Specialist is expected to take on other additional activities including projects and leadership of team initiatives.

Major Activities and Responsibilities:

• Project Management lead of regulatory projects related to federal submissions, (i.e., NDSs, SNDSs, etc.) for an assigned list of products.

• Preparation of Regulatory submissions and follow up with Health Canada until final Health Canada Regulatory decision. This includes interacting with Health Canada and being a primary contact with Health Canada with regards to the submissions.

• Ensures that all activities in relation to the registration of new products and their maintenance on the Canadian market are in compliance with the Food and Drugs Act and Regulations, all relevant Canadian guidelines, and the Company policies.

• Health Canada requests (safety signal assessment, requests for information, ATI, etc.) are immediately assessed, communicated to management & Global and managed as a priority and within required timelines.

• Safety Label Updates, PSUR, RMP filings are managed, as per local and global procedures.

• Filing and maintenance of CTA submissions with Health Canada, working in collaboration with Clinical Research colleagues and in compliance with local and global procedures.

• The incumbent will complete their tasks in a manner fully consistent with the Company’s commitment to its Code of conduct, Our Values and Standards, policies, procedures, industry standards and all Laws and Regulations. This includes the obligation to report all AEs and PQCs as per The Company policy, “Know to Report” Pharmacovigilance training, and Health Canada Regulations.

Other:

• Perform other activities as requested by the Director/Associate Director, Clinical.

• The incumbent must have a University Degree, B.Sc. or higher in Health Sciences or equivalent.

• The individual is expected to have strong communication and time management skills and the ability to work independently with minimal supervision.

• The Senior Specialist should have a minimum of 5 years’ experience and demonstrated success in Regulatory Affairs.

Functional Competencies:

• Awareness of Health Canada Food and Drug Act and Regulations and ability to interpret

• Knowledge of Regulatory Affairs science, concepts, and terminology

• Knowledge of the local operating procedures

• Understanding of company Global Regulatory Affairs organization, processes, and compliance expectations

• High level understanding and ability to interpret Health Canada Regulatory requirements and Guidance Documents that impact Clinical-related submissions

Skills:

Communication Skills

• Fluency in French is required

• Ability to communicate effectively verbally and in writing

• Knowledge of Good Documentation Practices

Computer Skills

• Excellent word processing, presentation, and spreadsheet application skills

• Familiar with the use of a large compliance databases

• Ability to learn new computer interface systems

Personal

• Excellent time management, organizational and planning skills

• High level of accuracy and quality in work

• Excellent collaboration and teamwork skills

• Compliance mindset/focused

• Courage and candor

This job posting is for an existing vacancy position .

The anticipated base salary range for this position is $98,560 - $147,840 CAD. At our company, we are firmly committed to provide fair and equitable pay for similar work and experience as a fundamental aspect of our workplace culture. Individual employee salaries will be based on several factors such as relevant experience, skills & proficiency, and/or other bona fide factors relative to appropriate internal comparators.

At our Company, we lead with people. This role includes eligibility to our discretionary short-term-incentive plan which fosters a pay-for-performance culture. Also, our contemporary rewards and benefit programs go beyond traditional medical plans and retirement programs, to create a flexible, inclusive workplace to support employee well-being, development and long-term success.

We may use artificial intelligence and automated tools to support our recruitment process. AI tools are used to support, but not replace, human judgment. All hiring decisions are made by our hiring managers.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

We encourage applications from all qualified candidates. In accordance with our accommodation policies and applicable provincial and federal accessibility legislation, we are committed to providing reasonable accommodation throughout the recruitment process.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

09/4/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.