Regulatory Compliance & Quality Control Manager

Job Overview:

The Regulatory Compliance and Quality Control Manager will oversee and manage regulatory affairs, compliance activities, and quality control processes. This role ensures that our products meet all regulatory requirements, industry standards, and quality control protocols and that the company maintains the highest level of compliance with local, national, and international regulations.

Key Responsibilities:

• Regulatory Strategy: Develop and implement regulatory strategies to support product development, market entry, and ongoing compliance.
• Compliance Oversight: Ensure compliance with all applicable regulations, standards, and guidelines, including cGMP, FDA regulations, and federal and state regulations.
• Documentation Management: Prepare, review, and submit regulatory documents to regulatory authorities, ensuring accuracy and completeness.
• Regulatory Intelligence: Stay current with regulatory changes and trends, providing guidance to the company on regulatory matters.
• Product Approval: Manage the submission and approval process for new products and changes to existing products, including clinical trials and product labeling.
• Internal Audits: Conduct regular internal audits to ensure compliance with regulatory requirements and company policies.
• Training: Develop and deliver training programs for staff on regulatory requirements, compliance best practices, and quality control procedures.
• Risk Management: Identify potential regulatory and quality control risks and develop mitigation strategies.
• Quality Assurance: Collaborate with the quality assurance team to ensure that products meet required quality standards and comply with SOPs.
• SOP Development: Develop, implement, and maintain standard operating procedures (SOPs) for quality control processes.
• Quality Control Management: Oversee quality control activities, including testing, inspection, and validation of products to ensure they meet established specifications and standards.
• Communication: Act as the primary contact for regulatory agencies, maintaining effective communication and facilitating inspections and audits.
• Reporting: Prepare and present reports on regulatory compliance, quality control activities, and overall performance to senior management.

Qualifications:

• Education:
  • Bachelor’s degree in Regulatory Affairs, Life Sciences, Chemistry, Biology, or a related field; advanced degree preferred.
• Experience:
  • Minimum of 5 years of experience in regulatory affairs, compliance, and quality control within the pharmaceutical, biotech, animal health, nutraceutical, or food industry.
• Skills:
  • In-depth knowledge of cGMP, FDA regulations, and other relevant regulatory requirements and guidelines for animal health products.
  • Strong analytical and problem-solving skills.
  • Excellent written and verbal communication skills.
  • Attention to detail and ability to manage multiple projects simultaneously.
  • Proficiency in regulatory document management and submission processes.
  • Experience with regulatory submissions and interactions with regulatory authorities.
  • Strong understanding of quality control processes and SOP development.
  • Ability to work collaboratively with cross-functional teams.
  • Strong organizational and project management skills.