Regulatory Affairs Professional with EU Market Expertise
Há 1 mês
About the Role
We are currently recruiting for a Regulatory Affairs Specialist to join our team in Sintra, Portugal. This is an exciting opportunity to work with a leading pharmaceutical company and contribute to the launch of new products.
Key Responsibilities:
- Handling post-approval activities related to Abbreviated New Drug Applications (ANDAs), Marketing Authorizations Applications (MAA), and variations/supplements to current ANDA/MA/ANDS.
- Evaluating Change Controls, preparing product information variations/labelling supplements, and providing information for Annual Product Review (APRs).
- Supporting the site on the launch of new products by performing all regulatory activities required.
- Preparing, reviewing, and implementing labelling.
Requirements:
- Masters degree in Pharmaceutical Sciences or equivalent experience.
- Experience in EU Market Regulatory Affairs is preferred.
- 4-6 years of professional experience in the pharmaceutical industry.
- Strong analytical and negotiation skills, as well as ability to work under pressure and meet deadlines.
What We Offer:
- A direct contract with our client company.
- A competitive salary of around €60,000 per year, commensurate with experience.
- Life insurance and health insurance benefits.
- An annual performance bonus based on individual performance.
About Us:
Adecco is a leading staffing agency providing temporary and permanent workforce solutions across various industries. We value innovation, customer satisfaction, and employee development.
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