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.
- BA/BS degree required in the natural sciences.
- A minimum of 3 years of relevant work experience required.
- Experience with either EPA or FDA registered 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 veal and written communication skills
- Strong negotiating, influencing and interpersonal skills
- Results oriented, entrepreneurial and self-motivated
- Excellent computer skills (Microsoft Office suite)
Feel free to forward my email to your friends/colleagues who might be available. We do offer referral bonus
Thank you for your time and consideration. I look forward to hearing from you!
Kind Regards
Ruchi Kumari
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I
(DIRECT BOARD) # 732-844-8716 (F) 732-549-5549
LinkedIn: https://www.linkedin.com/in/ruchi-kumari
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