Quality Assurance Regulatory Affairs Manager at Confidential
Interview Preparation Plan
The Quality Assurance Regulatory Affairs Manager is responsible for ensuring that the company's products and processes comply with all relevant national and international regulations and standards. This role bridges the gap between product development, quality control, and external regulatory bodies, ensuring that all quality assurance procedures meet the stringent requirements of the industry. The Manager will oversee the development, implementation, and maintenance of quality management systems, with a particular focus on regulatory compliance. This includes staying abreast of evolving regulatory landscapes, interpreting new regulations, and translating them into actionable policies and procedures for the organization. The role also involves managing regulatory submissions, audits, and inspections, and serving as a key liaison with regulatory agencies.
Key Responsibilities
- Develop and implement comprehensive quality assurance and regulatory affairs strategies.
- Ensure compliance with relevant industry regulations (e.g., FDA, EMA, ISO).
- Manage regulatory submissions, including product registrations, variations, and renewals.
- Oversee internal and external audits and inspections by regulatory authorities.
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