Description
My client is a leading provider of biopharmaceutical services. With more than 27,000 professionals working in more than 80 countries, they have helped develop or commercialize all of the top 50 best selling drugs on the market. They have extensive therapeutic, scientific and analytics expertise. They are looking to hire a regulatory affairs officer as a result of their continued growth.Regulatory Affairs officer responsibilities:
- Acts as a Regulatory Team Leader on small, straightforward regulatory projects and/or becomes involved in a small single service project, under the guidance of senior staff.
- Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate.
- Prepares and/or reviews regulatory documentation in area of expertise, as appropriate.
- Actively participates in project teams with internal and external customers
- Understands the Scope of Work, deliverables and management of budget for any given project.
- May prepare and deliver training, as appropriate
- Prepares and/or reviews regulatory submissions to support clinical trial and marketing authorisation activities for either internal and/or external clients.
- Provides regulatory support for assigned projects.
Experience required:
- Degree in life science-related discipline or professional equivalent
- Minimum 2-3 years regulatory experience in a pharmaceutical company
- Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate
- Good, solid interpersonal communication (oral and written) and organisation skills
- Demonstrates self-motivation and enthusiasm
- Ability to work on several projects, with direction from senior staff as appropriate
- Ability to follow SOPs consistently; provides independent thought to assist in process improvements
- Ability to make decisions on discrete tasks under senior supervision
- Write the science and interpret the medicinal chemistry and understanding of the clinical side would be an advantage but not essential.
An excellent salary plus benefits including health, pension and gym and health subsidies is on offer. This role is based in Dublin. Interviews will be immediate and this is a permanent role with excellent opportunities to grow and develop.
If you are interested in this position please contact me, Adele Moran, on for immediate consideration.
Sthree UK is acting as an Employment Agency in relation to this vacancy.