Regulatory Affairs Manager (9-month contract)
Skills
About the role
This is a 9-month contract role managing regulatory submissions and cross-functional coordination in the pharmaceutical industry. It suits a regulatory affairs specialist with project management skills who can work a hybrid schedule in Mississauga, Canada. AstraZeneca, a biopharmaceutical company, is hiring for this position.
What you’ll do
- Lead end-to-end planning, coordination and execution of assigned regulatory deliverables
- Contribute to regulatory submission strategy and identify risks and opportunities
- Provide regulatory guidance on procedural and documentation requirements
- Lead and contribute to preparation and delivery of submissions across the product lifecycle
- Develop and maintain submission delivery and content plans
- Coordinate project plans and flag resource changes to the lead and line manager
- Identify regulatory risks and propose mitigations
- Support operational and compliance activities including tracking and document management
- Provide coaching and mentoring within the regulatory affairs team
- Use AI tools to improve efficiency in regulatory work
What they’re looking for
- Relevant university degree in Science or a related discipline
- 2-4 years of regulatory experience in biopharmaceuticals, at a health authority, or equivalent
- General knowledge of drug development
- Strong project management skills
- Leadership experience with multi-disciplinary project teams
- Excellent written and verbal communication skills
- Proficiency with project management and document management tools
Nice to have
- Prior experience managing regulatory deliverables at the project level
- Thorough knowledge of the drug development process
- Knowledge of AstraZeneca's business and processes
What’s on offer
- Annual base salary ranging from 107,196.80 to 140,695.80
- Hybrid work, three days a week in the office
- Contract Benefits Program for fixed-term positions
Questions about this role
Is this role remote?
No, it is hybrid, with employees in the office three days a week.
How much does it pay?
The annual base salary ranges from 107,196.80 to 140,695.80.
How many years of experience do I need?
The posting asks for 2 to 4 years of regulatory experience.
Is this a permanent role?
No, it is a 9-month contract.
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