Regulatory Affairs Officer
il y a 2 semaines
ProductLife Group
Estimated Salary: €50,000 - €70,000 per year
About UsAt ProductLife Group, we are a leading pharmaceutical company that aims to provide innovative solutions for global healthcare needs. We are currently seeking a highly skilled Regulatory Affairs Officer / Linguistic Review Coordinator to join our team.
Job DescriptionWe are looking for a talented individual with experience in regulatory labelling operations in the pharmaceutical industry. The successful candidate will be responsible for coordinating and managing the Labelling team in charge of the Linguistic Review for our key clients' products.
- Coordinate and manage the Linguistic Review process for Centralized Procedure (CP) medicinal products, including linguistic reviews for new Marketing Authorization Applications (MAAs) and post-licensing changes.
- Manage the relationship with the Translation partner and facilitate the review and coordination of Linguistic Review processes with internal and external stakeholders.
- Provide ongoing support to project teams to ensure project concerns are planned and accounted for.
To be successful in this role, you will need:
Education:
- A Bachelor's Degree in Life Sciences, ideally a Pharmacy Degree (PharmD).
Experience:
- At least 1-2 years' experience in Regulatory Labelling Operations in a Pharmaceutical Company or Service Provider.
Skills:
- Good knowledge of regulatory labelling procedures.
- Experience in Project Coordination/Management.
- Ideal experience in Line Management.
- Good IT skills/knowledge and the ability to learn appropriate software.
- Good understanding of Microsoft Suite.
Soft Skills:
- Fluent English is mandatory, including excellent grammar skills (written and verbal fluency).
- Excellent organizational and interpersonal skills.
- Excellent oral and written communication skills, including facing clients.
- Ability to work well within a team and autonomously.
- Ability to prioritize different workloads/multi-task.
- Ability to deliver on tight timelines.
- Personal responsibility for ensuring a high standard of work.
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