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Head Regulatory Affairs

Employer
Barrington James
Location
Madison
Salary
Competitive

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Barrington James Board & Executive Partners are collaborating with a growing organization that is internationally known for its API production. With state-of-the-art facilities and a commitment to excellence, our client specializes in drug development, manufacturing, and quality control services. As a member of the Senior Leadership Team, you will play a critical role in ensuring compliance with regulatory requirements and maintaining the highest standards of quality throughout their operations. Your primary focus will be on leading the quality and regulatory function while implementing and enhancing the Quality Management System (QMS) to streamline processes, drive continuous improvement, and support their growth objectives. Are you a seasoned professional with a passion for quality assurance and regulatory affairs in the pharmaceutical industry? Do you thrive in a dynamic and fast-paced environment where you can make a significant impact? If so, please read further. Responsibilities Develop and implement an effective Quality Management System (QMS) aligned with industry best practices and regulatory guidelines. Define and maintain quality standards, policies, and procedures to ensure compliance with applicable regulatory requirements, including but not limited to GMP, FDA, and international guidelines. Lead and manage the quality assurance, quality control, validation, and regulatory teams, providing guidance, mentoring, and performance feedback. Ensure the timely review and approval of all quality-related documents, such as SOPs, protocols, validation reports, and batch records. Conduct internal audits and oversee external audits to identify potential compliance gaps and implement corrective actions as needed. Collaborate with cross-functional teams to drive the investigation and resolution of quality issues, non-conformities, and customer complaints. Stay up to date with regulatory changes and industry trends, proactively advising management on potential impacts and recommending necessary actions. Manage regulatory affairs activities, including the preparation and submission of regulatory filings, interactions with regulatory agencies, and maintenance of product registrations. Act as the primary point of contact for regulatory inspections, ensuring readiness and coordinating responses. Qualifications Bachelor's degree in a scientific discipline; advanced degree preferred. >5 years of experience in quality assurance or regulatory affairs in the pharmaceutical or biotechnology industry. Strong knowledge of regulatory requirements and guidelines, including GMP, FDA, and international standards. Proven track record in implementing and enhancing Quality Management Systems (QMS). Experience in managing and leading teams. Experience with regulatory inspections and interactions with regulatory agencies is desirable. Effective communication and interpersonal skills. Benefits Competitive Base Salary Enhanced Bonus Scheme Holiday Allowance Private Health Insurance Life Insurance Enhanced Pension Scheme Travel Allowances Clear Development Opportunities Following your application Francesca Hallworth, a specialist Pharmaceutical Recruiter will discuss the opportunity with you in detail. She will be more than happy to answer any questions relating to the industry and the potential for your career growth. The conversation can also progress further to discussing other opportunities, which are also available right now or will be imminently becoming available. This position has been highly popular, and it will likely close prematurely. We recommend applying as soon as possible to avoid disappointment. Please click 'apply' or contact Francesca Hallworth for any further information. Francesca Hallworth US & Europe Research & Drug Development Email: fhallworth (at)

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