Required Education Level:
Job Title: Regulatory Affairs Specialist
We are looking for a Regulatory Affairs Specialist to join our New Chapter team. The individual in this role will provide timely and effective regulatory leadership and support for New Chapter marketed products and initiatives.
The primary responsibility will include project management with cross functional teams as it pertains to Regulatory projects. This requires a great deal of flexibility, as priorities will change and time management will need to adjust accordingly.
Other Responsibilities include, but are not limited to:
- Project management and resources for PSRA. This includes updating Regulatory processes, SOP’s, tracking projects, coordinating of vendors and tracking of projects—necessary to facilitate growth of NCI business.
- Project management for CRT/Strategy teams. This includes facilitating weekly meeting, gathering substantiation documents for new sales and marketing materials for review and collaborate with cross-functional teams to ensure timely turnarounds.
- Familiarity with Administrator/Gate Keeper roles for the Veeva system for all sales and marketing collateral/labels/ packaging and artwork approvals. This includes gathering all substantiation document, managing the review and approval process for each team, providing on-going training and support to all users.
- Create reports and presentations for use inside New Chapter as it pertains to Regulatory or Safety.
- Provide regulatory support to teams included, but not limited to, attendance at technical project and team meetings.
- Maintain third party endorsements annual certifications for New Chapter products.
- Maintain raw materials as they pertain to third party certifications. Maintain communications and information between all parties involved in Raw Material Data Governance for Domestic and International countries (CA, UAE, etc).
- Work closely and collaboratively with the Raw Material Data Collector.
- Provide support to manage the regulatory affairs work associated with products and projects including relationships with consultants and contractors.
- Provide support for regulatory affairs labeling projects as needed.
- Provide regulatory input to various project teams.
- Track and monitor changes for company-wide SOP’s for additional training required within the department, attend departmental meetings, assist the budget owner in planning with multiple budgets for Safety, and Regulatory and Raw Material Data Governance.
- 0-3 years of previous regulatory and/or quality compliance experience or significant amount of indirect regulatory experience preferred.
- Diversity of cGMP experience; understanding of Part 101, 110, 111, and 117 regulations is a plus.
- Understanding of Global Regulations (FDA, Health Canada, UAE, etc) pertaining to these systems to ensure on-going compliance
- Experience working directly with FDA during auditing.
- Self-initiated/starter with project management capabilities. Must possess strong oral and written communication skills.
- Strong and highly organized leader who can support the roll out of multi-functional PSRA systems/work processes and lead the on-going management of those systems.
- Demonstrated technical skills, leadership skills and strategic thinking.
- Strong collaboration skills and ability to confidently represent the Regulatory position with cross-functional teams and to find solutions.
- Demonstrated attention to detail, willingness to do in-depth research and understand regulations, data, etc.
- Issue management and problem solving.
- Experience in database, spreadsheet, file management (ie, Microsoft Office, Navision, Veeva)
- Strong organization skills.
- Ability to work in a fast-paced environment and manage many shifting priorities.
- Team player.
New Chapter's mission is to deliver the Wisdom of Nature and take our healing mission to more people in more parts of the world.
Our online application will give you the option to apply to this role as a complete candidate – not just a resume. The application will assess your qualifications, personality traits and workplace preferences, and should take 10 to 15 minutes to complete. After submitting you'll receive an email allowing you to log in and view your assessment results and application.
We value diversity and inclusion and encourage all qualified people to apply. If you require any accommodation in the recruitment process, please contact us with the “Need Help” button in the application.
Please apply here: https://www.fitzii.com/apply/15608?s=bc