About This Opportunity: Senior Cmc Regulatory Affairs Specialist Charlottetown
GE Healthcare is currently seeking a Senior Cmc Regulatory Affairs Specialist Charlottetown to join their team in Charlottetown.
This position offers an excellent opportunity for motivated individuals looking to advance their career.
Education Requirements
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No specific education requirements
Required Experience
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Lead regulatory compliance as a Senior CMC Specialist dedicated to radiopharmaceutical development. Utilize your regulatory affairs experience to manage submissions and support global strategies effectively.As a seasoned qualified with at least 3 years in Regulatory Affairs, you will be a critical asset in supporting both marketed and investigational radiopharmaceuticals. This role facilitates collaboration across multiple departments, ensuring comprehensive data collection and regulatory compliance. Engage in regulatory discussions and provide expert advice for project teams to optimize business outcomes and resolve compliance issues.Key Responsibilities:
Serve as regulatory CMC strategy point of contact
Guide project teams in the planning phase
Develop input for CMC submission documents
Maintain detailed registration tracking information
Partner with global regulatory teams on inquiriesRequirements:
Advanced degree in pharmacy or related discipline
3+ years of regulatory experience in CMC
Knowledge of post
Position Details
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Location: Charlottetown
Key Responsibilities
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Effectively perform assigned job duties
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Maintain safety and cleanliness in the workplace
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Work effectively with team members
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Follow company policies and procedures
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Perform tasks according to quality standards
Qualifications
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Reliability and punctuality
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Ability to work independently and in a team
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Strong work ethic and positive attitude
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Ability to follow instructions
Why Join GE Healthcare?GE Healthcare offers a supportive work environment in Charlottetown, where employees can grow and develop their skills. This Senior Cmc Regulatory Affairs Specialist Charlottetown position provides the opportunity to work with a dedicated team and contribute to meaningful work.
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