Descripción de la oferta
BELIEVE IN LIFE. Join a company that takes you further!
Galenicum is one of the fastest growing companies in the pharmaceutical sector! We are enthusiastic about life, devoting our talent and effort to providing high-quality affordable pharmaceuticals worldwide.
People are the key to our present and future success, so we carefully select candidates that meet the requirements for each position, however most importantly, who also fit with our cultural DNA and values.
Here’s the lowdown on what your role will actually look like (spoiler alert: it’s awesome!)
We are looking for a Regulatory Affairs Expert to join our Regulatory Affairs Team!
What you'll be rocking:
Compilation, evaluation and submission of complete registration dossiers to specific regulatory agencies, of both, internal development and in-licensing products; under other RA team senior associate supervision. Contact with suppliers and clients, as needed, in order to obtain a dossier that meets the requirements of the country of destination.
Support in developing and writing clear arguments and explanations for deficiency letters.
Maintenance of approved dossiers and RA internal databases. Monitoring, updating and adapting documents, preparing submissions of variations and renewals to strict deadlines; under other RA team senior associate supervision.
Compilation and Evaluation of ASMF.
Writing clear, accessible product labels and patient information leaflets.
Review of marketing materials.
Audit or feasibility checks of dossiers to be registered in the required markets and coordination of the audits of the region.
Be updated on the regulatory requirements (EU, national and/or international legislation, as applicable, guidelines and customer practices) and registration procedures in all the company's export markets.
What you bring to the table:
Minimum between 6 months to 1 year experience in the area of registration of medicines for human use in the European Union and/or International markets, preferably generic drugs.
Very valuable to have experience in requirements in other markets.
Educational milestone:
Bachelor's degree in Medicine or Pharmacy, or other health sciences.
Preferably Master's degree in Regulatory Affairs.
Excellent level of scientific and business English, spoken and written.
Excellent computer skills.
Your key superpowers:
Highly disciplined, responsible, methodical, resolutive and organized individual.
Excellent oral and written communication and interpersonal skils.
Strong attention to detail and analytical frame of mind.
Understanding of both legal and scientific matters.
Capable to work under pressure and to strict deadlines, under your own initiative whilst being a good team player.
Able to find strategies according to legislation to solve problems and proposed innovative solutions for regulatory submissions.
Ability to prioritize multiple tasks.
What makes Galenicum a top-tier workplace?
A challenging company, and a dynamic team to work with.
A Workspace to enjoy. Pleasant, sustainable, and architecture-awarded office.
A flexible schedule to match your preferences and workload.
A training offer to learn beyond your job with a broad set of topics: Galenicum Laude.
Health insurance coverage to feel cared.
Food to keep your energy up. Subsidized meals in our office restaurant Popina.
Gym to help you maintain a healthy lifestyle.
Flexible remuneration.
And, very important! A Buddy to help you land smoothly in our company since day 1.
We’re looking for someone who works hard, plays hard, and laughs harder. Sound like you?
Come aboard. Believe in life
