Job Description

We are looking for a dynamic individual to join our growing Regulatory Team. If you are looking for a great opportunity with an established and growing privately owned company within the pharmaceutical industry, then we encourage you to apply. RESPONSIBILITIES:

• With the collaboration of RA/QA manager, help to formulate and explore regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance.
• Proactively communicate regulatory strategies, key issues and any other critical topics throughout the life cycle.
• Support submission activities (planning, authoring, reviewing, coordination, submission) and contribute to quality regulatory decisions, balancing risks and benefits.
• Facilitate submission approvals through effective communication and negotiation with partners, government agencies, and project team.
• Build positive working relationships with partners and government agency contacts.
• Provide partners with advice in response to their queries, based on regulatory experience and area of expertise.
• Conduct regulatory assessments for changes to marketed products.
• Review quality/technical documents (operational procedures, work instructions, protocols, validations, etc.) for appropriate scientific rationale and for adherence to regulatory requirements/guidance, development strategy.
• Other duties as assigned by management.

POSITION PRE-REQUISITES:

• Minimum B. Sc. in a Chemistry, Pharmacy or Life Science discipline
• Minimum of five (5) years Regulatory Affairs experience of filing Canadian and USA submissions, including electronic submissions in eCTD formats
• RAC certification is an asset.
• Expertise in chemistry and manufacturing, labeling and format requirements for drug product registration for in Canada and the USA
• Knowledge of the use of eCTD Software for preparing and filing submissions required
• Excellent interpersonal, written and verbal communication skills.
• Ability to plan, coordinate and work effectively in a team-oriented environment.
• Superior computer software skills (Microsoft Word, Excel, Access, PowerPoint, Adobe Acrobat, Document Management Systems).
• Strong organizational ability and management of multiple priorities combined with proven ability to meet strict and established timelines.

WORK LOCATION/TIMES:

• Remote / Hybrid with attendance to head office as required (Brantford, ON)
• Working hours in accordance with Company policy or as required.
• Travel may be required.

Remuneration negotiable and based upon experience. Job Types: Full-time, Permanent Salary: $60,000.00-$80,000.00 per year Benefits:

• Extended health care
• RRSP match

Flexible Language Requirement:

• French not required

Schedule:

• Monday to Friday

Work Location: One location