Corporate Compliance Clerk supporting Business Law team in London, Ontario, maintaining minute books and preparing corporate documentation. Requires 3+ years' experience and offers a hybrid work arrangement.
About the role
- Manager/Director, Technical Regulatory managing regulatory submissions for pharmaceutical products. Ensuring compliance with local and global standards in order to support timely approvals.
Responsibilities
- Performs the coordination and preparation of document packages for regulatory submissions for new and mature products
- Compiles all materials required in submissions, license renewal and annual registrations
- Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance
- Monitors and improves tracking/control systems
- Keeps abreast of regulatory procedures and changes
- May direct interaction with regulatory agencies on defined matters
- Recommends strategies for earliest possible approvals of clinical trials applications
- Works independently within guidelines and policies, receives minimal guidance
- Acts as a resource for colleagues with less experience and provides functional guidance
- Interact with regulatory agencies on defined matter
- Contribute to regulatory excellence by identifying opportunities, mitigating risks and supporting continuous improvement
Requirements
- Master’s Degree in life science disciplines is preferred
- 3 or more years’ work experience in the pharmaceutical, biotechnology or related industry in CMC, Regulatory, Quality, R&D, and Manufacturing or related
- Experience on generating technical registration dossier for China/EU/USA is preferred
- Analytical development, or MSAT, or manufacture process development, supply chain experience would be a plus
- Filing experience in Regulatory Affairs is a plus
- Knowledge of ICH, WHO, China regulations and guidance
- Knowledge of regulations and guidelines of other major markets (e.g. FDA, EMA) is a plus
- Proficiency with a wide range of data/information (CMC, clinical, non-clinical)
Benefits
- Our culture encourages personal expression, open dialogue, and genuine connections
- Embraced for the unique qualities you bring
- Valued, accepted and respected for who you are
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Senior Regulatory Specialist managing regulatory activities for pharmaceutical CMC projects. Collaborating with diverse teams and ensuring timely delivery of regulatory documentation and compliance.
Director of Regulatory Affairs leading drug product regulatory strategy and team management. Ensuring compliance and managing communication with FDA and regulatory bodies in a pharma environment.
Consultant for GMP compliance and quality assurance in Life Sciences. Engage in validation projects and assist in compliance documentation.
Senior Project Engineer focusing on GMP Compliance in the Life Sciences sector. Responsible for project planning, execution, and client communication in Mannheim, Germany.
Senior Consultant managing Compliance projects in the medical devices sector with a focus on Quality & Regulatory. Collaborating with a dynamic team in a leading GMP - expert company.
Regulatory CMC Manager supporting multi - product global regulatory CMC for products at Marketing Authorisation Application Stage. Focused on documentation preparation, submissions, and providing regulatory support.
Manage Vodafone's satellite communications policy and regulations while collaborating with teams. Engage in strategic initiatives and develop regulations to support satellite ambitions.
Compliance Analyst managing fraud prevention strategies and governance in Brazil's iGaming sector. Ensuring compliance with regulations and internal policies in a dynamic environment.
GRC Consultant implementing governance, risk, and compliance projects for cybersecurity at Redbelt Security. Evaluating processes and recommending improvements to enhance cybersecurity effectiveness.