Regulatory Manager | Bentley Labs

About the role

We are seeking a highly skilled Regulatory Manager to oversee the Regulatory Affairs department at Bentley Labs. This critical role involves ensuring that all products comply with applicable domestic and international regulations, supporting the development and launch of new products, and maintaining comprehensive regulatory documentation. The successful candidate will lead a team of regulatory professionals, collaborate closely with R&D, Quality, and Operations teams, and serve as the company's regulatory expert. The position requires a proactive approach to monitoring regulatory changes, preparing necessary submissions, and ensuring ongoing compliance to facilitate smooth product development cycles and market entry. The Regulatory Manager will play a key role in maintaining the company's reputation for regulatory excellence and supporting business growth through effective regulatory strategies.

Key facts

What you'll do

• Lead and manage the daily operations of the Regulatory Affairs team, setting priorities, assigning tasks, and ensuring timely completion of all regulatory activities.
• Review product formulations, marketing claims, and packaging to ensure they meet all relevant regulatory standards and guidelines.
• Prepare, review, and maintain essential regulatory documentation such as safety data sheets, product information files, and regulatory submissions.
• Oversee raw material compliance, including evaluating ingredient safety, sourcing documentation, and coordinating testing programs for cosmetic and OTC products.
• Support new product launches by ensuring all regulatory filings, notifications, and reports are completed accurately and on time.
• Manage product changes, reformulations, and label updates, ensuring compliance with current regulations and maintaining proper documentation.
• Mentor and develop team members, fostering a culture of continuous improvement, regulatory awareness, and professional growth.
• Monitor changes in FDA regulations, including MOCRA, OSHA, and other relevant standards, and advise internal teams on necessary adjustments to maintain compliance.
• Collaborate with R&D, Quality, Manufacturing, and Marketing departments to provide regulatory guidance during product development, testing, and commercialization processes.
• Maintain and update regulatory databases, tracking product registrations, certifications, and compliance statuses.
• Communicate regulatory updates and compliance statuses to senior leadership, ensuring transparency and proactive management of regulatory risks.
• Assist in preparing for and managing regulatory audits and inspections, ensuring readiness and compliance with all applicable standards.
• Support the company's compliance with ITAR regulations when applicable, ensuring proper handling of controlled technical data.
• Contribute to the development and implementation of regulatory policies, procedures, and best practices to streamline workflows and ensure consistency across the organization.
• Keep abreast of international regulations affecting cosmetic and OTC products, providing guidance on global market entry strategies.

Requirements

• Bachelor's degree in Life Sciences, Chemistry, Biology, Regulatory Affairs, or a related field.
• Between 3 and 5 years of experience in Regulatory Affairs, Product Compliance, or Quality Assurance within the cosmetics, personal care, or OTC industry.
• Demonstrated knowledge of FDA regulations, including MOCRA, and familiarity with cosmetic and OTC product compliance requirements.
• Proven ability to prepare regulatory documents such as safety data sheets, product dossiers, and compliance reports.
• Experience managing regulatory submissions, notifications, and change controls.
• Strong project management skills, with the ability to handle multiple priorities and meet deadlines effectively.
• Excellent communication skills, capable of collaborating with cross-functional teams and conveying complex regulatory information clearly.
• High attention to detail, accuracy, and thoroughness in documentation and reporting.
• Ability to interpret complex regulations and translate them into actionable compliance strategies.
• Knowledge of international cosmetic regulations and certifications is a plus.

Nice to have

• Previous experience leading a regulatory team or department.
• Background working with cosmetics or contract manufacturing organizations.
• Familiarity with USDA Organic certification processes and requirements.
• Experience with hazardous materials training, including DOT, IATA, and IMDG standards.
• Experience supporting regulatory audits and inspections.
• Knowledge of ITAR regulations and handling of controlled technical data.

Skills & tools

• Deep understanding of cosmetic and FDA regulations, including MOCRA and OSHA standards.
• Strong analytical and problem-solving skills, with the ability to interpret regulatory language and apply it effectively.
• Excellent organizational skills, with the ability to manage multiple projects simultaneously.
• Proficiency in regulatory databases and documentation management systems.
• Effective communicator, able to present complex regulatory information to diverse audiences.
• Collaborative approach to working with cross-functional teams to ensure compliance and product success.
• Attention to detail and accuracy in all regulatory documentation and reporting.

Practical notes

• This position is based in Edison, NJ, and requires working in an office environment.
• Occasional lifting of up to 25 lbs may be necessary for handling regulatory materials or samples.
• The salary range for this role is $90,000 to $100,000 annually, commensurate with experience and qualifications.
• Candidates should be prepared to work on-site in Edison, New Jersey, with no mention of remote or hybrid arrangements.
• The company values diversity and inclusion and encourages qualified individuals from all backgrounds to apply.
• Candidates should be ready to participate in regulatory audits and inspections, supporting the company's compliance efforts.
• The role may involve occasional travel for meetings, training, or regulatory agency visits, as needed.
• The company offers a collaborative and dynamic work environment focused on innovation and regulatory excellence.