Regulatory Affairs Interim

Full Job Description

Job Title: Regulatory Affairs Consultant (Cosmetics)

Company Overview: A leading company we represent is pharmaceutical company specializing in cosmetics, committed to delivering high-quality and innovative products that enhance the beauty and well-being of our customers. We are seeking a talented Regulatory Affairs Consultant with expertise in cosmetics regulation to join theteam and provide strategic guidance on regulatory compliance, quality management, and process improvement initiatives.

Position Overview: The Regulatory Affairs Consultant (Cosmetics) will play a critical role in ensuring compliance with regulatory requirements, optimizing quality management systems, and driving continuous improvement within our cosmetics division. The ideal candidate will have a strong background in cosmetics regulation, chemistry, change control, non-conformances, formulation reviews, and QMS systems.

Key Responsibilities:

1. Cosmetics Regulatory Compliance: Provide expert guidance and support on cosmetics regulatory requirements, including FDA regulations, EU cosmetics regulations, and other relevant standards, ensuring compliance throughout product development, registration, and manufacturing processes.

2. Change Control Management: Lead change control activities within the cosmetics division, including assessing the impact of proposed changes, evaluating regulatory implications, and implementing changes while maintaining compliance with applicable regulations and company procedures.

3. Non-Conformance Management: Develop and implement effective non-conformance management processes for cosmetics products, including investigation, root cause analysis, corrective and preventive actions (CAPA), and documentation, in accordance with regulatory standards and best practices.

4. Formulation Reviews: Conduct thorough reviews of cosmetic product formulations to ensure compliance with regulatory requirements, safety standards, efficacy claims, and labeling regulations, providing recommendations for optimization and improvement as needed.

5. Quality Management Systems (QMS): Collaborate with cross-functional teams to assess, enhance, and modernize the QMS for cosmetics products, ensuring alignment with regulatory expectations, industry best practices, and company objectives.

6. Process Improvement Initiatives: Identify opportunities for process improvements within regulatory affairs and quality management functions for cosmetics products, leveraging continuous improvement methodologies to enhance efficiency, effectiveness, and compliance.

7. Regulatory Documentation: Prepare and review regulatory submissions and documentation for cosmetics products, including ingredient listings, safety assessments, labeling, and claims substantiation, ensuring accuracy, completeness, and compliance with regulatory requirements.

8. Training and Education: Provide training and educational support to internal stakeholders on cosmetics regulations, quality management principles, and best practices, fostering a culture of compliance and continuous improvement.

9. Interdepartmental Collaboration: Collaborate closely with cross-functional teams, including Regulatory Affairs, Quality Assurance, Research & Development, Marketing, and Supply Chain, to ensure alignment of regulatory and quality objectives and effective communication across departments.

Qualifications:

• Minimum of 5years of experience in regulatory affairs within the cosmetics industry, with expertise in cosmetics regulation, change control, non-conformances, formulation reviews, and QMS systems.
• In-depth understanding of cosmetics regulatory requirements, including FDA regulations, EU cosmetics regulations, and other relevant standards governing cosmetic product development, registration, and manufacturing.
• Strong knowledge of quality management principles, including CAPA, risk management, document control, and quality system audits.
• Excellent analytical, problem-solving, and decision-making skills, with the ability to effectively navigate complex regulatory and quality challenges.
• Proficient communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders and influence decision-making at all levels of the organization.
• Detail-oriented approach with a commitment to accuracy, compliance, and continuous improvement.

Location: Manchester (on site)

Application Process: To apply for the Regulatory Affairs Consultant (Cosmetics) position, please submit your resume and cover letter detailing your relevant experience and qualifications.

We look forward to reviewing your application and considering you for this exciting opportunity to contribute to our mission of delivering high-quality and innovative cosmetics products to our customers worldwide.