Direct message the job poster from Jefferson Wells Italia
SCOPO DEL RUOLO:
Responsible for supporting global regulatory submissions and maintaining compliance with regulatory requirements for pharmaceutical products across multiple regions aligned with global regulatory strategies, with particular reference to EU. This role involves preparing regulatory dossiers, coordinating with health authorities, ensuring product registration, and providing regulatory guidance to cross‑functional teams.
Regulatory Submissions & Documentation:
* Prepare, compile, and submit global regulatory dossiers for new marketing authorization applications (MAAs), variations, renewals.
* Ensure timely and accurate submission of documents in compliance with global regulations.
* Support the labelling and change control processes to ensure timely and comprehensive review and approval of all packaging components (e.g., cartons, labels, Physicians Insert, Patient Insert, and Medical Guides).
* Maintain high‑quality regulatory documentation, ensuring it is consistent, accurate, and compliant with regulatory requirements in different regions.
Regulatory Compliance & Strategy:
* Support the development and implementation of global regulatory strategies for assigned products in collaboration with internal teams.
* Monitor regulatory changes and industry trends to ensure compliance with evolving guidelines and support the updating of regulatory strategies.
* Advise cross‑functional teams (R&D, Quality Assurance, Manufacturing, etc.) on regulatory requirements and strategies for market approval / lifecycle management.
* Contribute to the creation and maintenance of the Regulatory Affairs quality system, collaborating to the definition of processes and implementation of global standard procedures.
* Maintain knowledge of global regulatory requirements and trends, sharing relevant updates with internal teams.
* Contribute to regulatory intelligence activities and provide insights into global regulatory landscape developments.
* Track regulatory submissions, approvals, and regulatory activities using tracking systems and ensure timely reporting to management.
Requisiti:
* Good knowledge of EMA, ICH and FDA regulations, guidelines, and regulatory processes regarding drug development, approval, and maintenance of marketing authorisations.
* Strong organisational skills; good commercial and product awareness.
* Sound administrative and systems background.
* Minimum 3 years of experience in Regulatory Affairs in the Pharmaceutical Industry.
* Master Degree in scientific subject, preferable in Pharmacy or related. Master in Regulatory Affairs is considered a plus.
* Fluent in English, spoken and written.
* Master of Office.
* Familiarity with eCTD submission, compilation and publishing using specific tools.
Seniority level
* Associate
Employment type
* Full‑time
Job function
* Public Relations, Writing/Editing, and Accounting/Auditing
Industries
* Human Resources, Pharmaceutical Manufacturing, and Research Services
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