The Regulatory Affairs specialist B2C is in charge overview of the main activities related to the dossier of the products assigned, and contact with the main agencies and manage their queries and complaints.
Responsibilities:
· Compilation, evaluation and submission of registration dossiers to international regulatory agencies, of Company's developed products and licensing from other companies.
· Support in developing and writing deficiency letters.
· Monitoring, updating and adapting documents, preparing submissions of variations and renewals.
· Maintenance of approved dossiers.
· Review of marketing materials.
· Audit of dossiers to be registered in the international markets.
· Be updated of the regulatory requirements (international legislation, guidelines and customer practices) and registration procedures in all the company's export markets.
· Regulatory support to various departments of the company, including RA, QA, international.
· Regulatory intelligence to find the best way to submit dossiers in the different markets.
Requirements and skills:
· Bachelor's degree in Medicine or Pharmacy, or other health sciences.
· Master's degree in Regulatory Affairs.
· Excellent level of scientific and business English, spoken and written.
· Minimum 2 years' experience in the area of registration of medicines for human use in the European Union, preferably generic drugs. Very valuable to have experience in requirements in other markets.
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