Website Project Manager leading strategic website projects from planning through launch at POD Marketing, a Canadian full - service marketing agency. Managing clients, timelines, budgets, teams, and process improvements.
About the role
- Project Manager leading new product development regulatory submissions at Apotex, a Canadian pharmaceutical company. Managing due diligence, deficiency responses, risk mitigation, and product launch activities.
Responsibilities
- Lead New Product Development submission activities, including due diligence for new product opportunities, new product development submissions, and deficiency responses
- Develop regulatory project strategies with risk mitigation strategies
- Recover projects that are at risk
- Prepare and lead regulatory submissions according to current requirements and deficiency trends
- Assess potential deficiencies and coordinate with internal and external team members to address them
- Lead deficiency response strategies and finalize responses by target dates
- Conduct thorough due diligence of opportunities from the Business Development team and identify regulatory risks
- Request key elements from partners when initial data packages are incomplete
- Support seamless product launches through review of change proposals, change controls, documentation, and related activities
- Execute change control assessments and subsequent regulatory submissions or database updates
- Train and provide guidance to peers
- Collaborate safely as a team member and adhere to organizational values and compliance programs
Requirements
- B.Sc. in chemistry, biology, pharmaceutical, engineering, health sciences or a related field required
- Strong knowledge of regulatory requirements associated with new drug submissions
- Familiarity with technical/quality aspects associated with these products
- Excellent communication, presentation and interpersonal skills
- Excellent conflict management skills
- Strong organisational skills; ability to work independently and manage priorities
- Strong leadership skills
- Demonstrated knowledge of the generic new product development process
- Knowledge of Canadian and US regulatory guidelines
- Knowledge of and experience with the MS-Office suite of products
- 8+ years progressive experience in pharmaceutical regulatory affairs
Benefits
- Bonus programs based on position in the organization
- Comprehensive benefits
- Pension plan
- Learning and development opportunities
- Accommodation for applicants with disabilities
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