Senior Manager, Regulatory Affairs & Quality

Proclinical Staffing; Lake Hiawatha (NJ); Hybrid; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Senior Manager in Regulatory Affairs & Quality to lead compliance and quality assurance processes. This pivotal role involves overseeing regulatory strategies, managing a skilled team, and ensuring that products meet both regulatory requirements and quality standards. With a hybrid work schedule, this position offers the opportunity to work collaboratively across departments, including R&D, Marketing, and Sales. If you have extensive experience in the personal care or cosmetics industry and a passion for regulatory affairs, this could be the perfect role for you to make a significant impact.

Qualifications

• 15 years’ experience with a bachelor's degree or 10 years with a PhD/MS in relevant fields.
• Extensive knowledge of global regulatory frameworks for cosmetics and personal care products.

Responsibilities

• Lead regulatory compliance for chemicals in personal care and cosmetics across markets.
• Prepare and review regulatory documents including Safety Data Sheets and assessments.

Skills

Regulatory Compliance

Quality Assurance

Leadership

Knowledge of ISO 9000

Regulatory Frameworks

Quality Control Systems

Education

Bachelor's Degree in Science

PhD or MS in Chemistry/Biochemistry/Toxicology

Job description

Senior Manager, Regulatory Affairs & Quality

Senior Manager, Regulatory Affairs & Quality – Permanent – New Jersey

Proclinical is seeking a Senior Manager, Regulatory Affairs & Quality for a global chemical manufacturing company located in New Jersey.

Primary Responsibilities:

In this role, you will be responsible for leading both regulatory and quality assurance/control functions to support the Personal Care and Cosmetics division. This position will drive regulatory strategy and quality management processes, ensuring that products meet regulatory requirements and quality standards. The role also oversees the development of a skilled team of regulatory and quality professionals while working cross-functionally with R&D, Marketing, Sales, and Manufacturing.

The position is based in New Jersey in a hybrid work schedule.

Skills & Requirements:

• 15 years’ experience with bachelor’s degree, 10 years for a PhD or MS in a field of science is preferred (chemistry, biochemistry, toxicology, or relevant fields).
• Experience working in a quality environment involving quality systems and a knowledge of quality control.
• Previous leadership experience is required and regulatory experience in chemical, personal care/cosmetics or consumer care industries.
• Extensive knowledge of global regulatory frameworks for cosmetics and personal care products.
• Strong leadership experience with a proven ability to manage teams and foster collaboration.
• In-depth knowledge of ISO 9000, cGMP, IPEC, COSMOS, RSPO and relevant certification standards.
• Proven success in regulatory compliance, quality audits, and managing customer/regulatory inquiries.

The Senior Manager, Regulatory Affairs & Quality will:

• Lead and manage regulatory compliance for chemicals used in personal care, cosmetics, and other finished products across multiple markets (domestic and international).
• Prepare and review regulatory documents including Regulatory Data Sheets, Safety Data Sheets (SDS), Regulatory assessments, and other required documentation.
• Monitor, interpret, assess, and develop compliance strategies to address emerging regulations that impact our capability to manufacture, market, distribute, import, or export our solutions in domestic and global markets. Act as a regulatory representative with internal/external customers, communicating regulatory requirements and impact of regulations to the teams.
• Conduct regulatory assessments of chemical substances, monitor and support commercialization and marketing initiatives including safety and claims substantiation.
• Serve as the point of contact for external regulatory inquiries and act as the regulatory representative with customers and stakeholders.
• Manage Quality requirements, compliance and certifications for the site.
• Manage Quality Control lab and Quality Assurance personnel.
• Lead the site’s quality audits and manage customer and regulatory audits.
• Work closely with R&D, Sales, Marketing, and Operations to ensure regulatory and quality considerations are integrated into the product lifecycle.
• Communicate complex regulatory and quality issues clearly to both technical and non-technical audiences.