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Are you passionate about consulting? Are you motivated to develop creative solution to diverse problems? Do you dream about perfecting your knowledge and skills in a constantly changing global environment? If that is the case, the FOP CONSULTANTS company is tailor-made for you! We look forward to welcoming you in our team.
Located in the metropolitan area of Montreal, we are specialized to provide consulting services to companies in various fields, including: Pharmaceutical, Biopharmaceutical, Food industry, Cosmetics, and Medical Devices sectors. We also aim to expand our services to the sector of information and Communications Technology. We work closely with our clients to provide a tailor-made service that meets their needs and operational requirements. Thanks to our competent and qualified staff, FOP CONSULTANTS has as mission to serve clients in North America and elsewhere in the world.
Brief description of the position:
In order to meet the needs of our customers in the Pharmaceutical and Biopharmaceutical sector, we are looking for regulatory affairs consultants to carry out various mandates. The main missions would be to support all of the different departments in their regulatory requirements process, participate in staff training regarding regulatory instructions, write documents for the regulations authorities and collaborate on any project involved in pharmaceutical regulation.
Without limitation, the main tasks involve:
- Manage project related to the pharmaceutical regulations;
- Review and write documents for the submission of the regulation’s authorities;
- Ensure regulatory section is taken into account in every aspect of a project;
- Proceed to regulatory surveillance to be aware of any changing in order to reduce non conformity risks;
- Write the standard operating procedures (SOPs) related to regulations;
- Train or participate to the training of the personnel in charge of regulatory process;
- Support by your technical expertise the less experienced personnel;
- Participate to the weekly or monthly meetings about the regulatory cases;
- Provide solutions to problems encountered and perform all tasks relevant to the mandate;
- Bachelor’s or Master’s degree in sciences (Pharmaceutical, Chemistry, Biochemistry, Pharmacology, etc.), Drug Development any other related discipline;
- 1 (one) to 10 (ten) years of experience in pharmaceutical industries;
- Strong project management skills (an asset);
- Experience in regulatory affairs in pharmaceutical industries (an asset);
- Proven knowledge of Health Canada, EMA and FDA Regulations;
- Writing/oral communication skills, English and French;
- Perfect bilingualism (an asset);
- Valid class 5 driver’s license (an asset);
- Mobility, willing to travel (an asset).
- Rigor et discipline;
- Analytical and critical mindset;
- Able to manage several projects;
In order to allow the full development of our team members, FOP CONSULTANTS guarantee the support and comfort necessary for the achievement of their mandate. The main advantages offered are as follows:
- Competitive wages;
- Group insurance;
- Professional insurance;
- Remote work, according to the customer needs;
- Vacations: 3 weeks;
- Paid sick leave: 3 days;
- Monthly transportation fees;
- Career advancement opportunity;
- Continuing education.
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.
Level of education
Work experience (years)
Fr : Advanced
En : Advanced
Fr : Intermediate
En : Intermediate
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