Regulatory Affairs Specialist – Procedures

Tasks and Responsibilities: Prepares the strategy, the technical documentation, performs the submission (through national and EU portals) and follow-up until approval of MRP, DCP, CP and National Procedures for new marketing authorizations, variations, marketing authorization transfers and renewals according to the relevant EU Regulation and national requirements.
Gives support for the electronic submission (eCTD) and preparation of checklists and e-submission ready documents for different regulatory activities.
Gives support for the fulfilment of post approval requirements at local level (databases update, PI update, artworks revision, contacts with partners on behalf of MAHs).
Gives pre- and post-marketing regulatory consultancies concerning adherence to Italian regulations.
Performs the daily review of communications/regulations circulated by the Italian Authorities / EMA.
Manages the regulatory procedures in coordination with the Client's team and the contact with Regulatory Authorities together with or on behalf of the client.
Gives support to the Client in the critical evaluation of the appropriate regulatory strategy.
Essential Requirements: Degree in Pharmaceutical Chemistry and Technology, Pharmacy or similar.
Excellent knowledge of English (written and spoken), essential for frequent contacts with international companies.
At least 3 years of experience in similar roles.
Soft Skills: Communication and teamwork.
Attention to detail and organizational skills.
Time management and problem-solving.
Adaptability and resilience.
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