Regulatory Affairs Technical Manager

6 days ago

ireland RedChair Recruitment Full time

What we are looking for:

You will ensure that the requirements of the industry and regulatory bodies are fulfilled. You will be Responsible for the communications and interactions with the Competent Authorities in relation to the Authorized Representative duties. You will contribute to Regulatory Affairs activities across the company, ensuring successful and timely approval of all relevant regulatory submissions, ensure global regulatory compliance and to ensure delivery on corporate goals. Provide guidance on regulatory development activities and new product evaluations. To ensure successful collaboration between regulatory, clinical and quality assurance to support the business

Responsibilities Regulatory Affairs Technical Manager?

Responsible for preparation of Part 1 and CMC/Part 2 files for dossiers for Marketing authorisations Experience in Pharma regulatory affairs including time spent in Industry and/or in a regulatory agency/notified body with demonstrated understanding of and ability to interpret regulations and guidelines governing In-depth understanding of the required Pharmaceutical regulatory guidelines and standards Supporting product life cycle regulatory issues including post-marketing changes/variations, amendments, renewals, including all associated technical pharmaceutical studies Creating and overseeing studies needed, including technical/scientific input for pharmaceutical studies needed for sections of dossier preparation. In conjunction with the quality team – Providing technical and regulatory input to quality & QA for documentation associated with existing product manufacture Raw material and packaging specifications Liaise as needed with CMO’s, API suppliers, CRO’s providing technical and quality inputs on regulatory matters Active Member of the project team for new product development

Qualifications:

Possess the requisite expertise regarding the regulatory requirements for the Pharmaceutical Sector in the European Union demonstrated by a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned in, engineering or another relevant scientific discipline, Four years of professional experience in regulatory affairs or in quality management systems Ability to work independently and complete multiple assignments on time Knowledge and/or experience in International registrations and clinical studies is a plus.

Salary is open to negotiation depending on qualifications and experience and is aimed to attract the best. If you are interested please apply or email

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