Specialist/Project Manager, regulatory affairs

Brief description of the position :

In order to meet the needs of its clients in the (Bio)Pharmaceutical sector, FOP EXPERTS CONSEILS is looking for regulatory affairs consultants to carry out mandates. The main missions would be to support all the different departments in their regulatory requirement process, participate in staff training on regarding regulatory instructions, write documents for the regulations authorities and collaborate on any project involving in pharmaceutical products regulation.

Main responsibilities :

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.

Qualifications :

• Bachelor's or master's degree in science (chemistry, biochemistry, biology, pharmaceutical, pharmacovigilance, drug development, etc.), or any other related discipline;
• 1 (one) to 10 (ten) years of industry experience, preferably in (bio)pharmaceutical sector;
• Project management (an asset);
• Experience in regulatory affairs in the pharmaceutical field;
• Knowledge of regulations (Health Canada, FDA, EMA);
• Excellent skills in MS Office Suite;
• Good communication and writing skills in French and English;
• Mobility (an asset).

Personal skills :

• Leadership;
• Rigor et discipline;
• (Organize), able to manage several projects;
• Analytical and critical mindset;
• Perseverance;
• Humility.

What we offer :

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.