Medical Regulatory Affairs jobs
Senior Regulatory Affairs Associate
Easily applyUrgently hiringNutrasourceGuelph, ON- $75,000–$100,000 a year
- Full-time
8 hires made in past 30 days- Interacts with internal and external groups to provide regulatory affairs consultative support for projects.
- Initiates and manages regulatory affairs projects…
- DuchesnayBlainville, QC J7C 5E2
- Full-time +1
- Paid time off
- Vision care
- Dental care
- Life insurance
- Employee assistance program
- Disability insurance
- Lead assigned regulatory projects, ensuring compliance with regulatory requirements and timelines ;
- Ensure compliance with company procedures and applicable…
- Nora PharmaVarennes, QC
- Permanent
- Monday to Friday
- Vision care
- Dental care
- Life insurance
- Disability insurance
- Flexible schedule
- RRSP
- Create or revise labelling artworks, including primary, secondary, and any packaging components.
- Use tools and software’s for creation and updating…
- Applied Pharmaceutical InnovationEdmonton, AB T6N 1H1
- $75,000–$95,000 a year
- Full-time +1
- Paid time off
- RRSP match
- On-site parking
- Support internal quality audits and external inspections, ensuring compliance with regulatory standards and inspection readiness.
- Q MedicalNorth York, ON
- Full-time
- Monday to Friday
- On-site parking
- 3–5 years of experience reviewing medical and medico-legal reports.
- The primary responsibility of this role is to review and finalize complex medico-legal…
- NAPRAOttawa, ON
- Part-time
- The Pharmacist Specialist provides expertise in pharmacy practice that can be applied to NAPRA’s ongoing professional and regulatory affairs activities.
- Syneos - Clinical and Corporate - ProdRemote
- Full-time
- Serves as a member of the medical writing team for projects with medical writing deliverables.
- May compile medical writing deliverables.
- Syneos - Clinical and Corporate - ProdMEX
- Full-time
- Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies.
- Sound knowledge of cGMP, FDA, EMA, ICH.
- Syneos - Clinical and Corporate - ProdDesde casa
- Full-time
- Solid knowledge of RWLP operational and regulatory requirements.
- Our Clinical Solutions team members act with a drug development mindset, applying their years…
View similar jobs with this employerIBC Technologies Inc.Burnaby, BC- $100,000–$123,000 a year
- Full-time
- Paid time off
- Dental care
- Extended health care
- On-site parking
- Ability to translate complex regulatory information into compelling stakeholder-friendly language, including the importance of regulatory compliance and impact…
- Applied Pharmaceutical InnovationEdmonton, AB T6N 1H1
- $74,750–$97,750 a year
- Full-time +1
- Paid time off
- Vision care
- Dental care
- Employee assistance program
- RRSP match
- Work from home
- Support internal and regulatory audits.
- API offers a generous paid time off (PTO) policy that includes vacation days, medical/personal days, and holidays.
- Applied Pharmaceutical InnovationEdmonton, AB T6N 1H1
- $74,750–$97,750 a year
- Full-time +1
- Paid time off
- Vision care
- Dental care
- Employee assistance program
- RRSP match
- Work from home
- Support internal and regulatory audits.
- API offers a generous paid time off (PTO) policy that includes vacation days, medical/personal days, and holidays.
View similar jobs with this employerRheem ManufacturingBurnaby, BC- $100,000–$123,000 a year
- Full-time
- Paid time off
- Dental care
- Extended health care
- On-site parking
- Ability to translate complex regulatory information into compelling stakeholder-friendly language, including the importance of regulatory compliance and impact…
Lead Consultant (Hybrid)
Easily applyOften replies in 1 dayQ&C ServicesMississauga, ON L5N 1V8- $70,000–$85,000 a year
- Full-time +1
- Paid time off
- Vision care
- Dental care
- Life insurance
- Employee assistance program
- Profit sharing
- Completing critical assessments of data and documents to identify gaps compared to regulatory requirements.
- The role specifically prioritizes, plans, organizes…
- Syneos - Clinical and Corporate - ProdRemote
- Full-time
- Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs,…
- Syneos - Clinical and Corporate - ProdRemote
- Full-time
- Interacts and builds good working relationships with clients, department head, and team members in data management, biostatistics, regulatory affairs, and…
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Job Post Details
Senior Regulatory Affairs Associate - job post
Job details
Pay
- $75,000–$100,000 a year
Job type
- Full-time
Location
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