Regulatory Affairs Manager
Our client, a leading Canadian pharmaceutical company specializing in generic and natural health care products is looking for a Regulatory Affairs Manager to join their Montreal team. The person will be responsible for the oversight and preparation of various regulatory submissions to support timely approval of submissions (including clinical trials applications) and regulatory compliance/maintenance of the portfolio with applicable laws, regulatory guidelines, and policies.
- Register generic drugs, natural health products and medical devices according to Health Canada Standards and as per predefined timelines.
- Manage, plan, prepare and file the submissions/applications.
- Perform critical assessment of scientific data, gap analysis to meet Canadian requirements (chemistry, manufacturing, clinical and labeling).
- Prepare CTD summaries.
- Response to clarification requests as per Health Canada deadlines.
- Maintain regulatory compliance for approved/marketed products (amendments, annual notifications of chemistry, manufacturing, and labelling updates, etc.).
- Manage all aspects of product label content development and marketing material.
- Participate to the elaboration and implementation of regulatory strategies.
- Effectively liaise and negotiate with Health Canada (pre-submission meeting, clarifax, any other regulatory enquiries, etc.)
- Participate to due diligence activities.
- Effectively liaise with corporate partners, provide regulatory advice to other departments.
- Assemble, compile regulatory files (submissions, responses, etc.) in eCTD format, upload files in eCTD software and submit through CESG.
- Mentor Regulatory Affairs employees.
- University degree in life science discipline or equivalent.
- 5 to 8 years of experience in regulatory affairs within the pharmaceutical industry.
- Very strong scientific knowledge.
- Excellent writing and presentation skills in English.
- Good project management skills.
- Excellent knowledge of the Canadian regulations as well as ability to interpret policies and guidelines.
- Excellent communication skills in French and English (oral and written).
- Excellent knowledge of drug development process.
- Strong clinical knowledge.
- Experience in the generic field.
- Regulatory experience with different dosage forms.
- eCTD knowledge and experience.
- Autonomy and leadership.
- Solid problem-solving skills with an ability to identify solutions to problems under deadline constraints.
- Ability to work on multiple projects and structured work habits.
- Strong technical writing skills, and ability to review and critique regulatory documents.
- Ability to work independently with efficiency and accuracy and high attention to details.
If you are interested in this opportunity, please submit your resume to Céline Chabée using the “Apply” button.
You can also submit your resume directly to Céline Chabée at email@example.com, indicating “Regulatory Affairs Manager” in the title of the email.
Only selected candidates will be contacted.