Location: EirGen Pharma, Waterford
Title: Regulatory Affairs Officer
Reporting to: Senior Regulatory Affairs Officer
What will you be doing?
- Working within a team, responsible for a number of key projects with the following as examples –
- Dossier preparation in collaboration with our in-house R&D team (our R&D capacity is substantial with over 60 in the team and expanding all of the time) to support our generics portfolio. Dosage forms include high containment, tablets, capsules, soft gel capsules, dry powder inhalers and injectables. Territories are diverse and include US, EU, Japan and many ROW territories.
- Licensing support for OPKO’s portfolio new drug developments – some are authorised (one with an NDA in the US) and others are at various stages of clinical development with EirGen as the CMC Centre of Excellence and Supply Chain. Working with our licensing partners in US, EU and Japan for these new projects. IND support, Paediatric development and involvement in PIPs and PMRs for EU and US.
- Biologics – our new R&D facility houses a sterile fill finish line for manufacture of one of OPKO’s new biological products. Our Regulatory team will be closely involved in dossier preparation for global registration on completion of the Clinical program.
- Veterinary portfolio regulatory strategy – EirGen is developing a portfolio of new drugs for use in small animals with primary focus on US, followed by EU. Interaction with FDA and EMA on filing strategy and dossier content.
What we need from YOU:
- You MUST be passionate about Regulatory Affairs
- A degree in Chemistry or Pharmacy (or a related discipline)
- Ideally you will have 1 -2 year Regulatory experience, however other CMC focused Pharma experience considered
- Self-starter who enjoys working in a fast paced environment
- You MUST enjoy working as part of a team and be fun and friendly
What makes us different:
- We are a fun and exciting place to work!
- We have an incredibly broad range of products; Generics and New Drug developments; Human and Veterinary; we have a strong Clinical team in-house; substantial R&D capacity – all of which makes us very autonomous and self-resourced to deliver projects
- We encourage growth from within and like to promote our employees where we can
- We want to develop our employees and so we encourage them to undertake further training and courses wherever possible
- Diversity matters to us
- Our open door policy ensures that everyone’s ideas are heard
- Not too many pharma companies can boast that they have a purpose built R&D Centre located in the sunny South-East of Ireland!
If you match all the above criteria and want to join the Pharma Company of the Year – SME 2017, click below to apply!