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Regulatory Affairs Professional for Pharmaceutical Industry
2 months ago
We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to oversee clinical study regulations in the pharmaceutical industry.
About the Role:This is an exciting opportunity for a highly motivated individual to join our team at Altis Recruitment. As a Regulatory Affairs Specialist, you will be responsible for ensuring clinical studies comply with applicable regulations and guidelines.
Key Responsibilities:- Regulatory Compliance: Ensure clinical studies adhere to regulatory requirements, including FDA, Health Canada, and other international guidelines.
- Clinical Study Start-Up: Lead the start-up phase of clinical studies, managing necessary approvals and overseeing compliance.
- IRB Submissions: Coordinate IRB submissions to maintain adherence to regulatory requirements.
- Documented Processes: Update study manuals, protocols, and other relevant documentation as required.
- Communication: Act as the primary point of contact for communication with study sponsors and CROs.
- Regulatory Updates: Stay current on regulatory updates and best practices, maintaining expertise on FDA, Health Canada, and other international regulatory requirements.
- OHS Compliance: Conduct all work in accordance with the Occupational Health and Safety Act and related company policies and procedures.
- Experience: 2 years of experience in a medical, clinical, or research environment, with a focus on regulatory compliance or clinical research.
- Bilingualism: Bilingual in both official languages (English & French, oral and written).
- Accuracy and Thoroughness: Demonstrated ability to ensure accuracy and thoroughness in regulatory submissions and documentation.
- Regulatory Expertise: Capable of articulating regulatory requirements, negotiating with regulatory bodies, and effectively communicating compliance strategies.
- Data Evaluation: Skilled in evaluating complex data and identifying regulatory trends.
- Post-Secondary Degree: Post-secondary degree or diploma in health, law, science, management, or a related field, or an equivalent combination of education, training, and experience.
- Vacation and Holiday Closure: 3 weeks' vacation + holiday closure.
- Personal Days: Personal days, 10 stat holidays off, and sick days.
- Comprehensive Benefits: Comprehensive benefits plan (health, dental, and vision).
- RRSP Matching: RRSP matching up to 3% after 3 months.
