Regulatory Compliance Specialist

Title: Regulatory Compliance Specialist

Start: ASAP -  21/05/2023

Location: Janssen Sciences, Cork

Hours: 39 a week

The Company:

Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

Position Summary:

The JSI Regulatory Compliance Specialist is responsible for executing regulatory and compliance related tasks and project activities supporting both the Quality Assurance and Regulatory Affairs departments at JSI.

General Scope of Responsibilities:

The JSI Regulatory Compliance Specialist for Quality Assurance/Regulatory Affairs is responsible for completing regulatory requests for JSI in conjunction with the Regulatory Compliance Team Lead.

Key Role Activities:

• Maintenance of the Clinical and Commercial Health Products Regulatory Authority (HPRA) Manufacturing Licenses by preparing and submitting application updates in a timely manner.
• Collaborate effectively with Notary Public on the management of notarisation and legalisation requests. Ensure availability of related PO’s and appropriate logging and tracking of requests.
• Assist and coordinate with Regulatory Management on Country Specific requests (CSRs) for initial registrations and renewals.
• Coordinate paper-based inspections for product renewals and new submissions as per Health Authority timelines.

Experience and Education:

• Influence and facilitate the work of other departments and functions in achieving and maintaining state of GMP compliance. 
• Establish effective partnerships with other individuals, departments and GBSC affiliates so that compliance activities are well understood and coordinated. 
• Actively promote improvement programmes towards continuous compliance during qualification and validation. 
• Actively promote and apply strategic thinking to compliance activities Facilitates the work of other departments and functions in achieving and maintaining state of GMP compliance during qualification and validation activities. 
• Establishes effective partnerships with other individuals and departments so that quality systems and compliance activities are well understood and executed to a high standard. 
• Interface with all site departments, Operations and Maintenance. 
• Contact with Quality Assurance Manager for management of qualification and compliance activity. 
• Directors and managers of other departments for coordination of qualification document reviews and approvals, including associated change controls, non-conformance investigation, and completion of commitments.

Qualifications and Experience:

• Bachelor's Degree in a scientific/technical discipline required A minimum of 2 years experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry. 
• Demonstrated knowledge and application of industry regulations as they apply to qualification and validation, including those of FDA, IMB, EMEA and other authorities. 
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. 
• Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position. Desirable Experience in statistical sampling plan development. Experience in a bio pharmaceutical or pharmaceutical plant startup.

Diversity, Equity & Inclusion:

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

That is why we in Ireland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.

Thank you very much and we look forward to receiving your application.