Regulatory Affairs

Our client, a fast-growing distribution company who provides quality, affordable personal care and health products, is looking for a Regulatory Affairs & Quality Assurance Manager.

He/She will oversee and manage all quality control activities to ensure products or services meet established standards and regulatory requirements. This includes developing and implementing quality control systems, managing quality audits, handling customer complaints, and ensuring compliance with relevant regulations and coordination with regulatory authorities.

Key Responsibilities:

• Developing and Implementing Quality Systems:

This involves establishing and maintaining quality control systems, procedures, and documentation to ensure products or services meet quality standards and regulatory requirements.

• Managing Quality Audits:

Conducting internal and external audits to assess the effectiveness of quality systems and identify areas for improvement.

• Handling Customer Complaints:

Managing the process for receiving, investigating, and resolving customer complaints related to product quality or regulatory compliance.

• Ensuring Regulatory Compliance:

Ensuring that products and services meet all applicable regulatory requirements, including those related to safety, efficacy, and labeling.

• Managing Non-Conforming Material:

Overseeing the handling and disposition of non-conforming materials to prevent their use in production or release to customers.

• Supervising and Mentoring Staff:

Managing and mentoring QA/RA personnel, including providing training and guidance on quality control procedures and regulatory requirements.

• Working with Regulatory Agencies:

Interacting with regulatory agencies (e.g., FDA, EMA) on matters related to quality and regulatory compliance.

• Managing Corrective and Preventive Actions (CAPA):

Implementing and managing CAPA processes to address quality issues and prevent recurrence.

• Managing Supplier Quality:

Overseeing supplier qualification activities and monitoring supplier performance to ensure they meet quality standards.

• Developing and Delivering Training:

Developing and delivering training programs to employees on quality control procedures and regulatory requirements.

• Analyzing Data and Identifying Trends:

Analyzing data related to quality and regulatory issues to identify trends and areas for improvement.

• Reporting and Documentation:

Preparing and maintaining accurate and timely reports on quality and regulatory activities.

• Managing Product Registration and Licensing:

This may involve preparing and submitting applications for product registration, variations, or license renewals.

• Managing Artwork and Labeling:

This includes ensuring that product labeling complies with regulations.

Skills and Qualifications:

• Experience: Minimum 10 years of significant experience in quality assurance and regulatory affairs, particularly in a regulated industry (e.g., medical devices, pharmaceuticals, cosmetics, drugs and food).

• Education: With degree in Pharmacy and is a licensed Pharmacist

• Knowledge of Regulations: In-depth knowledge of relevant regulations (e.g., FDA regulations, ISO standards).

• Communication Skills: Excellent written and verbal communication skills to interact with internal and external stakeholders, including regulatory agencies.

• Analytical Skills: Ability to analyze data, identify trends, and develop solutions to quality and regulatory issues.

• Problem-Solving Skills: Ability to identify and resolve complex quality and regulatory issues.

• Leadership Skills: Ability to manage and motivate a team of QA/RA professionals.

• Project Management Skills: Ability to plan, organize, and manage projects related to quality and regulatory affairs.