A Senior Regulatory Affairs Specialist is required by CareerWise Recruitment for our Galway based client. At our client's Regulatory Affairs department, they focus on harnessing otheir collective strength to deliver best-in-class solutions that benefit patients and cross functional partners. Senior Regulatory Affairs Specialists are directly involved in regulatory activities supporting the global commercialization and sustaining of products on the market in compliance with all regulatory requirements. Please contact Tom Devaney for more information.
Role of this position
- As part of a team of regulatory affairs professionals you provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
- Prepare regulatory submissions for new products and product changes as required to ensure timely approvals for market release and/or clinical studies.
- Provide post market maintenance support to commercial products as necessary to ensure ongoing regulatory approval. This includes supporting global re-certification activity, reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Prepare submissions and reports for filing directly with EU & US regulatory agencies and support other international agencies as required by product status.
- Interact directly with external regulatory agencies (FDA, notified bodies etc.) and/or indirectly with international regulatory agencies on applicable projects/products.
- Support regulatory compliance activities, including manufacturing site registration & regulatory agency audits as needed.
- Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
- Develop internal procedures to ensure continuous compliance with all regulatory requirements.
- Identify and develop best practices within the Regulatory Affairs department including continuous development initiatives (MOS/COS)
- Ensure personal understanding of all quality policy/system items that are personally applicable.
- Follow all work/quality procedures to ensure quality system compliance and high-quality work.
- Level 8 Bachelor's Degree/Masters or equivalent in Science, Engineering or related discipline.
- Regulatory experience is desirable, however, candidates with a minimum of 5 year's relevant experience will also be considered.
- You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams.
- You are experienced with Microsoft Word, Excel and PowerPoint, and knowledge of Adobe Acrobat, Data Management Systems are desirable
- You have strong technical knowledge. You are skilled in thinking critically and making sound decisions.
- You collaborate with others and create alignment with team members.
- You set high standards and drive accountability in the execution of your responsibilities and you model ethical behavior.
- You are a good communicator and fluent in English, both in writing and speaking with strong organizational skills.
Please call Tom Devaney today for further information on 091-758771 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)