Regulatory Affairs Specialist
- Provide day-to-day support for both existing and new product development activities, focusing primarily on labeling reviews.
- Provide regulatory guidance to Marketing regarding labeling requirements and product specifications for North America.
- Review and approve copy sheets and product artwork to ensure compliance with regulatory requirements.
- Assist in coordinating cross-functional projects, prioritizing tasks, managing meetings, updating timelines, identifying project risks and following up on forward actions and deliverables.
- Collaborate with cross-functional teams to gather necessary information to ensure projects are completed successfully and within assigned deadlines.
- Develop best practice/work instructions and apply recommended improvements to departmental and cross-functional procedures.
- Oversee invoice processing and collaborate with Finance to optimize the payment process.
- Provide assistance with export document requests for global product registrations.
- Lead and coordinate Funding the Growth initiatives for the function.
- A bachelor’s degree is required, preferably in life sciences (e.g., chemistry, biology) or business administration.
- Understanding of the U.S and Canadian regulatory requirements for drugs and cosmetics.
- 3+ years of regulatory experience is required
- Proficiency in Google Workspace (Sheets, Slides, Documents) is essential.
- Previous experience in project management roles is preferred.
- Effective project coordination and organizational skills.
- Ability to lead cross-functional teams and work effectively in a matrix environment.
- Strong attention to detail and a high degree of accuracy in work.
- Excellent communication and problem-solving skills.
- site
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