Our client in Parsippany, NJ is looking for a Regulatory Associate Manager. Our client is a multinational manufacturer and marketer of health, hygiene, post-natal and home products.

 

The Regulatory Associate Manager has the ability to work autonomously to oversee day-to-day Regulatory Affairs activities for specific area(s) of responsibility.

Responsibilities:

• Advanced ability to interpret and apply applicable FDA regulations and guidances, as well as interpret enforcement trends governing dietary supplements. Mentor and direct others in their understanding and application of regulations and guidances.

• Apply knowledge and experience to increasingly complex regulatory issues and show ability to share knowledge and experience with cross-functional peers.

• Create and review Supplement Facts Panels to support artwork development.

• Provide regulatory guidance on Advertising, Labeling and Promotional Materials as a member of the cross-functional LMR Committee.

• Lead development of regulatory strategies and provide regulatory strategic advice to team for successful launch of VMS products.

• Set clear priorities, review project progress with ability to provide gap analysis and resolutions to lead team to achieve targets; balance resources, quality and speed to market.

• Apply best practice Project Management methods, anticipating contingencies, team response and readiness in advance.

• Lead team to achieve targets for integration activities and plan/manage external projects that arise.

• Ability to steer productive meeting discussions to assure regulatory compliance.

• Skilled in using available programs, Systems, and industry resources to assure best in class regulatory compliance.

• Departmental representative for system development projects. Provide support/direction to others on the functionality of systems.

• Work with cross-functional team to prepare, review and/or approve applicable SOPs and Work Instructions, as well as enforce best practices and SOP conformance.

• Proactively identify regulatory issues and areas that may require improvement.

• Oversee support of a high quality and effective infrastructure to meet the regulatory requirements to support the launch of compliant products.

• May be active participant in trade association committees and other key external partnerships to help maintain industry awareness and support internal best practices and communication strategies.

• Perform tasks as required to ensure regulatory compliance while effectively managing business risks.

• Support Quality and Safety organizations in Dietary Supplement/VMS matters as needed.

 

Qualifications:

• BA/BS degree required in the natural or food sciences area.

• 6 -10 years of relevant work experience required.

• Experience with dietary supplement products required.

• 3+ years of management experience desired.

• Strong Project Management skills required.

• Experience with FDA registered products a plus.

• Prior experience working in the CPG and/or Healthcare industry preferred.

• Strong 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.

• Must be agile, able to multi-task and prioritize multiple deliverables within aggressive timelines.

• Strong verbal and written communication skills.

• Strong negotiating, influencing and interpersonal skills.

• Results oriented, entrepreneurial and self-motivated.

• Excellent computer skills (Microsoft Office Suite).

Job Types: Full-time, Temporary, Contract

 

Salary: $50.00 to $55.00 /hour