Benefits
- Commitment to work-life balance
- Disability insurance
- Floating leave days
- Insurance
- On-going training
- Paid leave
- Paid sick leave
- Performance bonuses
- Reimbursement for public transportation
New
Telecommuting
specialists in regulatory affairs (Sr.)
FOP Experts Conseils inc.
202-9420 Boulevard Taschereau, Brossard,QC- Salary To be discussed
-
37.50 to 40.0 h - Full time
-
Contract ,Permanent ,Telecommuting job
-
Day shift work
-
3 positions to fill as soon as possible
Description
POSITION DESCRIPTION
CANDIDATE PROFILE
WORK MODE
WHAT WE OFFER
Read more
FOP CONSULTANTS is looking for specialists in regulatory affairs at the senior level motivated to deliver on mandates for its clients in the pharmaceutical and biopharmaceutical sector. The mandate is to define regulatory strategies and prepare eCTD submission filings for Health Canada and the FDA and to manage post-approval changes, review labelling and maintain marketing authorizations through ongoing regulatory intelligence. The senior scope is further to define the regulatory strategy and the approval timeline and to mentor intermediate consultants and review their submissions.
KEY RESPONSIBILITIES- Prepare and submit regulatory filings (NDS, ANDS, IND, NDA) in eCTD format.
- Define regulatory strategies for development and market authorization.
- Assess the regulatory impact of changes and manage post-approval changes.
- Serve as liaison with Health Canada, the FDA and other agencies.
- Review labelling, monographs and promotional material.
- Provide regulatory intelligence and communicate new requirements.
- Maintain marketing authorizations, establishment licences and DINs.
- Define the regulatory strategy and the approval timeline.
- Mentor intermediate consultants and review their submissions.
- Lead exchanges with Health Canada, the FDA and foreign authorities
CANDIDATE PROFILE
- Bachelor's or master's degree in science (chemistry, biochemistry, biology, pharmaceutical, pharmacovigilance, drug development, etc.), or any other related discipline.
- Minimum ten (10) years of industry experience.
- Eight (08) to fifteen (15) years of experience as a Specialist in Regulatory Affairs.
- Sector standards: GMP (Health Canada), FDA 21 CFR 210-211, ICH Q7 to Q10, GAMP 5, ISO 9001.
- Tools and systems: MS Office suite, Veeva Vault RIM, eCTD, regulatory databases.
- Hold one of the following certifications: RAC (RAPS), regulatory affairs certification.
- The following are considered assets: ASQ CQA, PMP, intellectual property training.
- Experience in Canadian public or private organizations.
- Language: French and English
WORK MODE
- Remote, Hybrid, On-site
WHAT WE OFFER
At FOP CONSULTANTS, we invest in the success and well-being of our experts. By joining our team, you benefit from an environment designed to support your performance and respect your work-life balance, including:
- Competitive compensation that reflects your expertise;
- Complete protection through our group insurance plans;
- Professional liability insurance so you can practise with confidence;
- Remote-work flexibility, based on client needs;
- 3 weeks of vacation to recharge;
- 3 paid sick days, to take care of yourself;
- A monthly allowance for your transportation costs;
- Real opportunities for advancement within the organization;
- Ongoing access to training to grow your skills.
Work environment
Equal Opportunity Employer
This employer is an equal opportunity employer committed to diversity and inclusion. We are pleased to consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veterans status, Aboriginal/Native American status or any other legally-protected factors. Disability-related accommodations are available on request for candidates taking part in all aspects of the selection process.
Requirements
Level of education
University
Diploma
BAC
Completed
Work experience (years)
10+ years
Written languages
Fr : Advanced
En : Intermediate
Spoken languages
Fr : Advanced
En : Intermediate
Other FOP Experts Conseils inc.'s offers that may interest you
- Share this page
- Share on Facebook
- Share on Twitter
- Share on LinkedIn
- Print the offer
More similar jobs like "specialists in regulatory affairs (Sr.)"
-
specialists in regulatory affairs (Int.)
Brossard,QC
Published today
-
specialists in process validation (Sr.)
Brossard,QC
Published today
-
specialists in quality assurance (Sr.)
Brossard,QC
Published today
Search more jobs
We create the perfect match
Jobillico displays the best jobs that fit your profile.
Upload your resume
job seekers also viewed.
-
SharePoint Specialists (Sr.)
Brossard,QC
-
SharePoint Specialists (Sr.)
Quebec City,QC
-
specialists in process validation (Int.)
Brossard,QC
