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Regulatory Associate Labeling
Location: Morris County, NJ
Salary: TBDK+ Bonus
**This is a Perm/Salary Job. NO Third Parties, Sponsorship is Not available.
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.
Demonstrate strong project management skills by ensuring project deliverables and timelines are met.
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 Guidances
Assess the impact of new regulations and guidance. Work with stakeholders to implement
Requirements within specified timelines.
Keep current with all relevant guidance 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 the client. 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 spebrand-specifices 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 the client. 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
· BA/BS degree required in the natural sciences.
· A minimum of 2 years of relevant work experience required.
· Experience with FDA over the counter drug products is required.
· Experience in consumer products industry is highly preferred (a must if only experience is R&D).
· High attention to detail and strong organization skills
· Ability to establish close communications and working relationship with cross functional teams to meet business objectives
· Ability to work with uncertainties and effect innovative solutions to complex regulatory requirements
· Strong verbal and written communication skills
· Strong negotiating, influencing and interpersonal skills
· Results oriented, entrepreneurial and self-motivated
· Excellent computer skills (Microsoft Office suite)
· Strong attention to detail
· Strong project management skills is required
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