Regulatory Associate

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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