Job Description

We are seeking a meticulous and dedicated Regulatory Affairs and Quality professional to ensure our pharmaceutical products meet regulatory and quality standards. The successful candidate will be responsible for creating and maintaining quality assurance documentation, as well as working closely with regulatory bodies.Key Responsibilities:

• Regulatory Leadership:

• Develop and implement global regulatory strategies to ensure compliance with diverse regulatory requirements globally, particularly regulated markets.
• Lead and manage regulatory submissions, approvals, and post-market surveillance activities.
• Maintain strong relationships with regulatory agencies and industry stakeholders.
• Provide expert guidance on regulatory requirements and industry best practices, with a deep understanding of sterile manufacturing regulations.
• Oversee the preparation and submission of regulatory dossiers to various global health authorities, including USFDA, UK-MHRA, and TGA-Australia.
• Proven track record of successfully handling and leading regulatory audits and inspections.
• Corporate Quality:

• Oversee the development and implementation of corporate quality systems and standards, including those specific to sterile operations.
• Ensure compliance with Good Manufacturing Practices (GMP) and other relevant quality regulations, especially concerning sterile product manufacturing.
• Lead internal and external audits and inspections, with a focus on sterile facility compliance.
• Drive continuous improvement initiatives to enhance quality processes and patient safety, with emphasis on sterile process optimization.
• Strategic Planning & Execution:

• Develop and execute strategic plans to support the company's growth objectives.
• Provide leadership and guidance to the Regulatory and Quality teams.
• Collaborate with cross-functional teams to ensure alignment with business goals.
• Team Leadership & Development:

• Lead and mentor a team of regulatory and quality professionals.
• Foster a culture of excellence, collaboration, and continuous learning.
• Manage the Head of Regulatory and the Head of Corporate Quality Assurance.

Qualifications:

• Bachelor's or Master's degree in Pharmacy (preferred) or a related scientific discipline.
• Minimum of 20+ years of experience in regulatory affairs and quality assurance within the pharmaceutical industry, with significant experience in sterile manufacturing.
• Extensive experience in managing global regulatory submissions and approvals, particularly for sterile products.
• Deep understanding of international regulatory standards and guidelines, including USFDA, UK-MHRA, and TGA-Australia, with specific expertise in sterile manufacturing regulations.
• Proven track record of leading and developing high-performing teams, especially in sterile operations.
• Strong leadership, communication, and interpersonal skills.
• Excellent analytical and problem-solving abilities.

Leadership and Growth in a Complex and Critical FieldOpportunity to lead high-performing teams, & to grow with the companyA successful RA & CQA professional should have:

• An educational background in Life Sciences or a related field.
• Experience in working with regulatory bodies in the pharmaceutical industry.
• Strong understanding of quality assurance practices and regulatory compliance.
• Excellent communication and interpersonal skills to liaise with various stakeholders.
• Ability to manage multiple tasks and work under tight deadlines.
• Problem-solving skills to identify and address quality issues.

Our client is a large organization in the Life Sciences sector, specifically in the Pharmaceutical industry. They are well-respected and established, known for their commitment to quality and adherence to stringent regulatory standards. With a global footprint, they continue to make significant contributions to the healthcare industry.

• A collaborative and supportive company culture that values employee growth and development.
• The opportunity to work in a large organization making significant contributions to the healthcare industry.
• Unique opportunities for professional development in the Life Sciences sector.

Take the next step in your career in the Pharmaceutical industry and join a large organization that values quality and regulatory compliance.

Michael Page