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Regulatory Affairs Technical Manager, Ireland
Client: RedChair Recruitment
Location: Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: 4e246d98a00c
Job Views: 2
Posted: 27.04.2025
Expiry Date: 11.06.2025
Job Description:
* You will ensure that the requirements of the industry and regulatory bodies are fulfilled.
* You will be responsible for communications and interactions with the Competent Authorities regarding Authorized Representative duties.
* You will contribute to Regulatory Affairs activities across the company, ensuring successful and timely approval of regulatory submissions, global compliance, and achievement of corporate goals.
* Provide guidance on regulatory development activities and new product evaluations.
* Ensure collaboration between regulatory, clinical, and quality assurance teams to support the business.
Responsibilities of Regulatory Affairs Technical Manager:
* Preparation of Part 1 and CMC/Part 2 files for marketing authorization dossiers.
* Experience in pharmaceutical regulatory affairs, including industry and/or regulatory agency experience, with understanding and interpretation of regulations and guidelines.
* Deep understanding of pharmaceutical regulatory guidelines and standards.
* Support for product lifecycle regulatory issues, including post-marketing changes, variations, and renewals, with associated studies.
* Creation and oversight of necessary studies, including technical and scientific input for dossier sections.
* Provide technical and regulatory input to quality and QA teams for documentation related to manufacturing, raw materials, and packaging specifications.
* Liaise with CMOs, API suppliers, and CROs on regulatory matters.
* Participate actively in new product development projects.
Qualifications:
* University degree or equivalent in engineering or relevant scientific discipline, demonstrating expertise in EU pharmaceutical regulatory requirements.
* At least four years of professional experience in regulatory affairs or quality management systems.
* Ability to work independently and manage multiple assignments; experience with international registrations and clinical studies is a plus.
Salary is negotiable based on qualifications and experience. Interested candidates should apply or email us.
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