Senior Regulatory Affairs Specialist
a biotech company listed on the Milan Stock Exchange and a leader in the development of innovative anti-tumor therapies, is looking for a highly motivated and qualified Senior Regulatory Affairs Specialist who will report to the Regulatory Affairs Manager and will provide support in formulating and implementing regulatory strategies for the development of Company Products in close collaboration with other functions in the Clinical Department.
Lead and manage activities concerned with the submission and approval of products and product transfers to government regulatory agencies including US and EU regulatory bodies:
Develop content, timelines and contingencies for submissions in collaboration with internal and external contributors
Ensure that submissions are of high quality, meet all regulatory requirements and comply with corporate goals and directives
Gathering, evaluating, and organizing information necessary for regulatory agencies and other third parties;
Coordinate and participate in the preparation of different types of regulatory submissions (e.g. dossier, variations, scientific advice submissions, INDs) to competent authorities worldwide for approved and developmental products
Provide regulatory feedback to project teams and senior management
Participate in contacting competent authorities for respective projects/products and interact with internal departments
Performing the registration, update and posting of results of Philogen studies in mandatory clinical trials and publication databases;
Prepare and revise controlled documents including clinical Forms, Templates and Standard Operating Procedure (SOPs) referred to the Regulatory Affairs;
Training clinical staff in regulatory policies or procedures;
Keeping up-to-date with changes in regulatory legislation and guidelines and evaluating applicable laws and regulations to determine impact on department activities;
At least 5 years' experience in regulatory affairs
Experience in Regulatory Life Cycle Management and eCTD is an advantage, although not required
A thorough understanding of ICH GCP and regulatory requirements worldwide (particularly FDA and EMA)
Excellent written and oral communication skills.
An excellent level of English, both written and spoken.
A contract and salary proportional to the experience of the successful candidate
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