Regulatory Affairs Specialist
We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Cork. This is an exciting opportunity for anyone looking to work with a leading multinational organization.
Responsibilities:
* Provide technical support for vaccine drug substance and/or drug product processes to ensure compliance with regulatory requirements.
* Support the development and implementation of process change control documentation, technical communications, and process risk management strategies.
* Collaborate with cross-functional teams to ensure the successful support and commercial manufacture of pharmaceutical products.
* Lead the identification and assessment of partner risks and develop mitigation plans.
* Provide manufacturing process support to External Partners to resolve production issues and optimize process and capacity.
* Coordinate investigations and manage interface with other impacted manufacturing sites.
* Review and approve External Partner process change requests, deviations, and Master Batch Record changes.
Requirements:
* A Bachelor's degree in Engineering or applicable Science is required; an advanced degree is preferred.
* Experience in pharmaceutical manufacturing, engineering, and/or technical support of operations is essential.
* Excellent leadership, collaboration, change management, interpersonal, analytical skills, and communication skills (both verbal and written) are required.
Benefits:
This role offers a unique opportunity to work with a leading multinational organization and contribute to the development and implementation of process change control documentation, technical communications, and process risk management strategies.
About Us:
Our organization is committed to innovation and excellence in the pharmaceutical industry.