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Medical Affairs Hospital jobs in Ontario

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    • Interacts with internal and external groups to provide regulatory affairs consultative support for projects.
    • Initiates and manages regulatory affairs projects…
    • Exposure to medical sciences and/or the pharmaceutical industry.
    • Coordinate with clients, medical editors and internal team members for successful project…
  • View similar jobs with this employer
    • Ability to identify unmet medical, educational, and research needs at the local and regional level in the medical community.
    • PhD, PharmD, MD, or DO required.
    • View all Arrowhead Pharmaceuticals jobs - Toronto jobs - Liaison jobs in Toronto, ON
    • Salary Search: Medical Science Liaison salaries in Toronto, ON
    • The Regulatory Affairs Associate is responsible for planning, coordinating, compiling, submitting, obtaining approval, maintaining drug product registrations…
    • Demonstrated knowledge of Ontario healthcare legislation, medical staff governance, hospital operations and research regulations.
    • Knowledge of regulations governing medical information exchange with healthcare professionals within the Canadian pharmaceutical environment.
    • Licensed for independent medical practice and in good standing with the College of Physicians and Surgeons of Ontario.
    • Range - $400,700 - $400,744.93.
    • While the majority of this role will provide strategic operational leadership that enables the Centre, it also includes some dedicated finance management…
    • Collaborate closely with internal stakeholders (sales management, marketing, medical affairs, market access) to ensure cohesive and high-impact execution;
    • Ensure appropriate documentation and tracking of medical inquiries.
    • Provide strategic medical input for cross-functional collaboration.
    • A minimum of ten (10) years of relevant senior management experience is required, preferably within a medical school, university, hospital or healthcare setting…
    • TL identification, profiling, segmentation and engagement planning: Responsible for executing medical strategy by translating the local medical plan into…
    • C ontribute to the success of the Canadian Regulatory Affairs team by fostering collaboration, alignment, accountability, and high-quality execution across…
    • Conduct timely review of commercial/medical materials.
    • The Regulatory Affairs Manager, Canada, is responsible for the regulatory activities for the assigned…
    • The Head of Medical Affairs, Oncology is a senior leadership role responsible for shaping and executing the medical affairs strategy for Takeda’s Oncology…
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Job Post Details

Nutrasource logo

Senior Regulatory Affairs Associate - job post

Nutrasource
120 Research Lane, Guelph, ON
$75,000–$100,000 a year - Full-time

Job details

Pay

  • $75,000–$100,000 a year

Job type

  • Full-time

Location

120 Research Lane, Guelph, ON

Full job description

Position Overview

Our rapidly expanding team is seeking a Senior Regulatory Affairs Associate to support regulatory sciences and clinical operations teams located in Guelph, ON. The Senior Regulatory Affairs Associate will provide leadership and support for various regulatory projects. The main responsibilities of the successful candidate will include the oversight and preparation of various regulatory submissions to support clinical trials and market access while ensuring compliance with applicable global policies, procedures, and regulatory guidelines.

Primary Responsibilities:

· Preparation and oversight of regulatory submissions and related documentation to primarily Health Canada, including Natural Health Product (NHP) Clinical Trial Applications (CTAs), Master Files, and Product License Applications (PLA), according to current Agency requirements.

· Interacts with internal and external groups to provide regulatory affairs consultative support for projects.

· Initiates and manages regulatory affairs projects to ensure content complies with emerging or new requirements.

· Identifies gaps in submission dossier to meet local requirements.

· Leads and provides guidance in the development and implementation of regulatory strategies.

· Liaises with functional areas to coordinate and compile information required for regulatory documentation.

· Interprets and makes decisions relating to regulatory guidelines and policies.

· Advises management on changes to regulations, standards and legal stipulations, and ensures SOPs and Work Instructions are updated to reflect such changes.

· Liaises with Health Canada and other regulatory agencies, as needed.

· Keeps abreast of domestic and global regulatory trends, laws. and movements.

· Maintains positive and cooperative communications and collaboration with all internal and external stakeholders.

Core Competencies:

· Knowledge and experience in the Natural Health Products Regulations, associated regulatory principles, processes, and industry standards.

· Excellent communication skills with an ability to translate regulatory and scientific complexities into actionable guidance.

· Strong understanding of safety and efficacy evaluations.

· Excellent organizational time management and communication skills.

· Excellent interpersonal and public relation skills with ability to work well in a team.

· Solid problem-solving skills with an ability to identify solutions to problems under critical deadline constraints.

· Strong technical writing skills, and ability to review and critique regulatory documents.

· Ability to work independently with efficiency and accuracy and high attention to detail.

· Computer literacy with MS Office and Adobe Acrobat.

Qualifications:

· Advanced degree in a scientific discipline such as Pharmacology, Toxicology, Nutrition Science, Biochemistry, Regulatory Science, or related field.

· 8+ years of increasing responsibility in Regulatory Affairs/Regulatory Sciences for natural health products, supplements, OTCs, or similar regulated sectors.

· Proven experience preparing and submitting Class I–III NHP applications.

Pay: $75,000.00-$100,000.00 per year

Work Location: In person

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