Title: Regulatory Associate
Duration:6 Months (Possibility of Extension)
Location: Parsippany NJ
Job Responsibilities:
- Provide Regulatory Support for Current Products and Development Projects
- Execute strategy and provide regulatory support and input.
- Deliver projects and other initiatives to progress current product portfolio by providing regulatory direction and support to stakeholders:
- Collect and collate data required for registration submissions.
- Prepare submission packages for the appropriate Regulatory Agency.
- Correspond with the appropriate Federal or State Agency regarding registration submissions.
- Review product labeling and supporting materials.
- Implement New Regulations and Guidance’s
- Assess impact of new regulations and guidance’s.
- Work with stakeholders to implement requirements within specified timelines.
- Keep current with all relevant guidance’s and regulations while monitoring any changes that occur which may impact the current business.
- Assess and communicate all requirements to stakeholders in order to maintain compliance without delay to business due to regulatory issues.
- Adjust and monitor timelines to support the business.
- Support Infrastructure and Systems Integration
- Contribute to supporting a high quality and effective infrastructure to meet the regulatory requirements which support the launch of associated products within NA.
- Execute systems integration for optimal functionality and use.
- Contribution to infrastructure (processes, procedures, systems etc.) to be made within agreed upon timelines.
- Deliver project and brand specific activities assuring they are correct, complete and on-time including registrations, submissions, labeling/advertising initiation/reviews, etc.
- Gain Understanding of Legislative and Regulatory Climate
- Understand how the government operates and key touch points can access to influence policy development.
- Monitor trade associations and task forces that support .
- Monitor ongoing legislative and competitive developments.
- Monitor and gain an understanding of new policies and objectives involving federal and local government affairs.
- Review trade association materials (newsletters, meeting minutes, agenda items) to gain an understanding of where influencing opportunities exist.