Regulatory Affairs Project Manager

2 months ago

Brantford, Canada ACIC Pharmaceuticals Inc. Full time

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

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