Chief of Regulation overseeing programmatic and operational activities for Florida's Division of Licensing. Responsible for budget management and ensuring compliance with policies and procedures.
About the role
- Regulatory Affairs Intern assisting with clinical submissions and chemical manufacturing documentation for pharmaceutical lifecycle support. Providing regulatory assistance and managing project documentation.
Responsibilities
- Support for regulatory submission activities related to clinical operations: converting product monographs into a new format; assisting in the preparation of documents for clinical activities; preparing a response template (question-and-answer document) to address Health Canada requests.
- Support for chemistry, manufacturing and controls (CMC) activities and projects: tasks related to certified product information documents (DCIP); tasks related to applications for pharmaceutical establishment licences (LEPP); assisting in the preparation of documents for CMC activities; preparing a response template (question-and-answer document) to address Health Canada requests.
- Support for labeling and proofing activities: reviewing artwork and proofs required for regulatory filings; maintaining tracking tools, databases, and product registers; supporting Special Access Program activities by preparing supporting documentation for Special Access Program drug requests.
- Regulatory correspondence and archiving of regulatory documents: archiving correspondence and documents in an electronic repository.
- Support for tracking/databases for environmental assessment needs: documentation related to environmental assessment reports.
Requirements
- Must hold a university degree in health sciences or equivalent
- Must excel in communication and time management and be able to work independently with minimal supervision
- Ability to work collaboratively with others (internal and external)
- Strong communication skills to convey and receive information in English and French
- Good organizational skills and ability to prioritize tasks
- Attention to detail and commitment to quality of work
Benefits
- Flexible work arrangements
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Compliance Business Oversight Manager managing compliance risk at TD Bank. Overseeing Affiliate Transactions Data Review and providing insights on regulatory compliance.
Regulatory Affairs Professional creating clinical evaluation documents for medical devices in a fast - growing biotech company. Collaborating with stakeholders and ensuring compliance with regulations.
Manager overseeing regulatory affairs for a German implant company in facial and trauma products. Ensuring compliance with regulations, preparing submissions, and advising on medical affairs.
Compliance Manager reviewing broker - dealer and registered investment adviser communications for regulatory compliance. Working collaboratively with diverse business partners in a hybrid work environment.
Compliance Officer providing regulatory compliance support within the asset services business line. Managing compliance frameworks and guiding risk owners on regulatory obligations.
EMEA Regulatory Specialist providing regulatory support at Univar Solutions. Alongside a global team to handle customer inquiries and compliance in the chemical sector.
Regulatory Affairs Coordinator maintaining regulatory documents for research projects at Geneva. Overseeing IRB application processes and supporting research staff with documentation and compliance.
Trade Compliance, Customs and Sanctions Manager role providing compliance advisory on trade controls and customs at Vodafone. Key responsibilities include risk management and stakeholder collaboration on global trade activities.
Regulatory Associate at Reckitt ensuring compliance with global regulatory requirements for new product developments. Collaborating to create comprehensive product registration dossiers and navigate regulatory landscapes.