Regulatory Associate/Sr Regulatory Associate

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds….

ClinChoice is searching for a Regulatory Associate/Sr Regulatory Associate - Consultant  with HYBRID option in Summit, NJ for 6 months CONTRACT, to join one of our major consumer products clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture.

Purpose of the Role

The Ingredient Compliance Associate will support the NA ingredient stewardship program by serving as a subject matter expert for ingredient-related regulatory compliance. This individual will monitor, interpret, and assess regulatory developments impacting ingredients used across the OTC, cosmetic, and consumer health portfolios. They will also contribute to authoring and updating Standard Operating Procedures (SOPs), databases, and guidance documents to ensure robust compliance monitoring and risk management.
This role is critical to maintaining business continuity, providing timely ingredient assessments, and supporting strategic decision-making across R&D, Quality, and Regulatory Affairs during a period of heightened regulatory activity.

Scope of Work & Key Deliverables

1. Ingredient Regulatory Monitoring & Assessment
    Track, summarize, and communicate new or emerging ingredient regulations, restrictions, and safety assessments (e.g., FDA, Health Canada, MoCRA, Proposition 65, PFAS, color additives, etc.).
    Identify and evaluate potential impacts of ingredient changes on existing or future products within the North America portfolios.
    Support the development of internal ingredient compliance summaries and decision trees for impacted business partners.

2. SOP Development & Documentation
    Draft, revise, and implement SOPs and Work Instructions related to ingredient compliance monitoring, horizon scanning, and risk evaluation.
    Align SOPs with global regulatory frameworks and internal governance standards.
    Partner with Regulatory Policy & Intelligence Lead to standardize documentation and ensure audit-ready compliance systems.

3. Ingredient Database & Record Management
    Contributes to the maintenance and enhancement of the ingredient regulatory database and associated risk registers.
    Ensure traceability of ingredient regulatory assessments and alignment with global safety and formulation databases.

4. Cross-Functional Collaboration
    Collaborate with R&D, Safety, Quality, Legal, and Labeling to ensure compliant ingredient use across all categories.
    Provide expert input into formulation reviews, supplier inquiries, and new product development initiatives.
    Support ad hoc regulatory intelligence requests related to ingredient status or permissible use.

5. Reporting & Communication
    Deliver concise weekly updates on ingredient trends and potential compliance risks.
    Provide monthly summary reports of key ingredient issues, risk mitigation actions, and progress on SOP deliverables.

Required Qualifications

Bachelor's degree in scientific discipline
Experience in regulatory affairs, medical affairs, toxicolgy or ingredient compliance within OTC, cosmetics, personal care, or consumer health industries.
Demonstrated understanding of ingredient safety evaluations, global substance restrictions, and chemical inventory requirements.
Strong communication skills with the ability to develop and implement SOPs.
High attention to detail, scientific rigor, and ability to manage multiple priorities in a fast-paced environment.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

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