An exciting opportunity has arisen within an international drug product manufacturer, to take up a maternity cover placement within the Regulatory Affairs team. Flexible working, family healthcare cover, perfect public transport access, free lunch, 25 days AL, pension and an excellent working atmosphere are just some of the benefits provided.
If you are interested in this job apply below. I also have more senior or indeed junior roles within Engineering, QC, QA, QP, Validation, CQV, PM and other areas of pharmaceutical, medical device, and biologics companies. Send me an email or simply your CV to schedule a confidential chat (014744692) - to andrius "at" sigmar.ie
- Responsible for managing the product authorisations of assigned national products, and national regulatory aspects of assigned centralised products.
- Communication of changes to product licences and the distribution of updated SmPCs to the relevant internal personnel.
- They will be responsible for the information flow from the Global Regulatory Group to relevant colleagues ensuring that the relevant individuals are fully up to date with the regulatory status of companies products.
- They will be responsible for the publication of SmPCs for assigned products and the updating/maintenance of associated artwork.
- Responsible for the preparation of Abridged Prescribing Information for Promoted products and regulatory review of promotional materials.
- Preparation of Dear Healthcare Professional Communications (DHPCs) and ensuring the timely printing and distribution of these.
- Responsible for the regulatory maintenance of assigned clinical trials.
- Responsible for the regulatory aspects of temporary product shortages or product discontinuation notifications.
- Represent the regulatory function in cross-functional teams /task forces to support the business.
- BSc (life sciences/health sciences degree) OR clear demonstration of scientific knowledge/aptitude
- A min of 1 years’ experience in regulatory affairs or similar experience within a highly regulated environment
- Basic working knowledge of core processes; discovery, development, manufacturing and marketing;
- Commitment to performance measures of time, costs and quality
- Strong written and verbal communication skills
- Proven track record of dealing with multiple stakeholders
- Demonstrates leadership, proactivity and department level approach to work, thinking beyond immediate responsibilities and applying knowledge to situations outside the scope of their projects.
- Excellent attention to detail and accuracy
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