Senior Regulatory Affairs Specialist

Philogen S.p.A. is a biotechnology company listed on the Milan Stock Exchange and a leader in the development of innovative anti‑tumor therapies. As we expand our clinical development activities, we are strengthening our Regulatory Affairs organization.

We are currently seeking a highly motivated, experienced 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.

Responsibilities

• 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.
• Review draft registration files and submit new and amended registration dossiers to obtain and maintain registration.
• Gather, evaluate, and organize 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.
• Perform the registration, update and posting of results of Philogen studies in mandatory clinical trials and publication databases.
• Manage procedures related to Marketing Authorisation Applications for EMA and FDA.
• Manage the update of the Trial Master File and archiving of the documentation regarding the Competent Authorities and Ethics Committees of all Philogen studies in collaboration with the CTA.
• Prepare and revise controlled documents including clinical forms, templates and standard operating procedures (SOPs) referred to the Regulatory Affairs.
• Train clinical staff in regulatory policies or procedures.
• Keep up to date with changes in regulatory legislation and guidelines and evaluate applicable laws and regulations to determine impact on department activities.
• Preferably have experience of, but definitely an awareness of the key electronic submission tools.

Requirements

• University degree in science (preferred).
• At least 5 years of 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.
• Excellent level of English, both written and spoken.

Benefits

A contract and salary proportional to the experience of the successful candidate.

Job location

Senior Regulatory Affairs Specialist • Lombardy, Italia

Our recruitment adheres to the provisions of Legislative Decree 198/2006, and we welcome applications from candidates of any gender orientation or expression, sexual orientation, age, ethnicity, or religious belief.