Regulatory Affairs Expert Position
We are looking for a Regulatory Affairs Expert to join our Regulatory Affairs Team.
Responsibilities
* 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.
Qualifications
* 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.
Benefits
* 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.
* Versátil remuneration.
* A Buddy to help you land smoothly in our company since day 1.
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