Regulatory Specialist – OTC at RB
Posted in General Business 15 days ago.
This job brought to you by eQuest
Location: parsippany, New Jersey
A fantastic opportunity is available for a Regulatory Specialist - OTC to join our Regulatory team.
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. Demostrate 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, advertising, promotional materials against supporting documentation.
- Create/proofread/approve artwork.
Implement New Regulations and Guidances
- Assess impact of new regulations and guidances. Work with stakeholders to implement requirements within specified timelines. Keep current with all relevant guidances and regulations while monitoring any changes that occur which may impact the current RB 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 RB 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 RB can access to influence policy development. Monitor trade associations and task forces that support RB. 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.
Is this You?
- BA/BS degree required in the natural or food sciences.
- A minimum of 2 years of relevant work experience required.
- Experience with FDA over the counter drug and/or dietary supplement 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
- Fast paced. Tired of having to jump through endless hoops to get things done? Not here. We move fast and deliver .
- Growth. Frustrated by the lack of growth opportunities in your current company? Not here! RB takes pride in the development and continued growth of our employees through steady rotations and promotions.
- Autonomy. RB empowers you to OWN what you do.
- Iconic Global Brands. http://bit.ly/RBNABrands Take a look. You'll be surprised at how many you already have in your home.
- Feel good about the company you work for! RB is committed to making the world a better place through bette rb usiness. http://bit.ly/rbsustainability
- Passport Stamps. Does working Internationally interest you? Perform well and Global doors can open for you at RB.
- Work with smart people. We have a talented workforce that believes in sharing ideas to help each other, and the company succeed.
- Vacation. We offer 4 weeks' vacation, 9 core Holidays and 4 floating days.
16 weeks paid Maternity leave.
Competitive base salaries and bonuses.
In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly Global organisation.
Apply Now for a chance to really change the game!
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.