Montréal, QC H4S 1Z9 Canada
+1 (438) 923 9257
Institution : CERASP – Center of expertise in applied research in the pharmaceutical sciences
Title: REGULATORY GUIDANCE and GRANTS OFFICER
Reference number : OFF-REGO-2021-002
Work Location : Ville St-Laurent
Title of Immediate Supervisor : Senior Researcher
Position Status : Permanent Full-time
Job Category : Employee
Posting Start Date : 09/01/2021
Posting End Date and Time: 10/13/2021 11:59pm
Salary Scale: Based on experience
CERASP adheres to an Equal Access to Employment Program, and invites women, visible minorities, ethnic minorities, aboriginal peoples and persons with disabilities to submit their applications.
Do you have an entrepreneurial spirit? Do you drive projects and love to learn? Is customer service a mission for you? Then maybe you are the person we are looking for? The CERASP, a center of excellence in pharmaceutical innovation, is a Non-Profit organization affiliated to John Abbott College and CEGEP Gerald Godin. We have a mission to develop and support applied research, training and technology transfer related to the discovery, development and evaluation of innovative solutions in the pharmaceutical field. We aim to help Quebec’s industry and biopharma, pharmaceutical and cosmetics industry by offering effective and profitable solutions through applied research of the highest level, the development and dissemination of innovative and pioneering technologies in biopharmacy, pharmaceutical technology, pharmaceutical production and digital health, as well as participate in the training of Quebec’s future pharmaceutical industry workers.
The primary role of the Regulatory and Grants officer is to guide clients on their regulatory pathway and well as coordinate with the Senior researcher. This is a role for a person who has experience, but isn’t necessarily an expert. You will need to be open to learning new things, asking questions, making contacts and managing your time well as there are always new things to incorporate. Reporting to the Senior Researcher, you will:
DUTIES AND RESPONSIBILITIES:
• Prepare reports for clients about the requirements to submit CTAs for small molecules, biologics and natural health products to Health Canada Directorates (TPD, BGTD, NHPD) and the Office of Controlled Substances (OCS);
• Have a clear understanding of the expectations of Health Canada and other regulatory agencies;
• Provide strategic advice on regulatory requirements to clients;
• Serve as a resource for regulatory documentation (such as CTD/Nee/eCTD format requirements);
• May participate in drug development files to be submitted to regulatory bodies (e.g., pre-IN, IND, pre-CTA);
• Keep abreast of regulatory guidelines (such as Health Canada’s TPD, NHPD and BGTD, FDA) and ensure processes are adjusted as required;
• Provide in-house training courses to new and existing employees as required;
• Represents CERASP and SMEs at meetings /scientific or business meetings;
• Contribute to regulatory product assessments;
• Contribute to regulatory information and feasibility initiatives;
• Facilitate the management of regulatory information requests for timely resolution and identification of opportunities for improvement.
• Write high quality grant proposals, descriptions, applications and supporting documents
• Responsible for research, data collection and writing grants
• Manage the proposal submission process to ensure punctual submission of all required documents.
• Develop and maintain a proposal schedule;
• Coordinate and monitor progress of submitted proposals
• Collaborate with the Executive Director to develop an annual grant strategy and conduct research to find, cultivate and solicit new grants
We are looking for:
• Good knowledge of Health Canada and FDA standards and guidelines; Knowledge of CMC, pharmaceutical manufacturing and analytical chemistry (asset); Experience in filing and managing regulatory submissions, including electronic submission in eCTD formats (asset); Experience in filing and managing grant submissions, including NSERC and FRQNT; Good verbal and written communication skills; Understanding clinical research, drug development process and regulatory guidelines; Knowledge and understanding of the Canadian regulatory framework for non-prescription pharmaceuticals, natural health products, cosmetics and product-related promotional statements. Knowledge and understanding of the Canadian regulatory framework for medical devices is an additional asset.
• Excellent organizational and work ethic.
• Excellent interpersonal skills.
• Ability to work effectively in cross-functional teams and be self-sufficient.
• Strategic ability.
• BSc. in Life Sciences (Certification/Regulatory Affairs training is an asset)
• Three (3) to five (5) years regulatory experience preferred;
• Bilingual (French & English). Fluency in English is an asset.
Testing may be required to demonstrate knowledge of:
• English – advanced (oral, comprehension, written)
• French – advanced (oral, comprehension, written)
• Regulatory procedure development Health Canada, Grant submission process NSERC and FRQNT
• Word (intermediate)
• Excel (intermediate)
To apply, please send your CV and cover letter detailing key experiences related to this posting to email@example.com
mentioning reference number OFF-REGO-2021-002
We thank all candidates who submit their resumes for consideration. However, only those candidates selected for an interview will be contacted. We will keep you CV on file for 1 year should a new position open.