SENIOR REGULATORY AFFAIRS MANAGER
Philogen is a Swiss-Italian integrated biotechnology company founded in 1996, with the mission to develop innovative biopharmaceuticals for the treatment of angiogenesis-related disorders.
Philogen would like to hire a
Senior Regulatory Affairs Manager responsible for providing strategic regulatory intelligence, guidance and regulatory expertise for product development from clinical through registration and product optimization.
In particular, the successful candidate will be responsible for:
- Manage US / EU submissions such as new marketing authorization applications, lifecycle management activities and responses to Health Authority questions.
- Author high-quality documentation and/or review documentation CTD sections, IMPD, BLA, etc. for Health Authority submissions (CTA, MA, etc.).
- Formulate and lead global regulatory strategy for assigned development projects maximizing the business benefit balanced with regulatory compliance.
- Maintaining knowledge up to date of all current applicable regulations and proactively participating in the design of global regulatory strategies.
- Making sure that all necessary documentation is completed and submitted in compliance with applicable government regulations.
- Acting as the liaison with other Philogen divisions keeping each department informed of applicable regulations and monitoring compliance.
- Acting as the liaison between Philogen and the Regulatory Authorities on CMC related topics. Leading preparation of meetings with regulatory agencies as needed and ensure regulatory issues impacting global regulatory strategy for proposed marketing filings are considered.
- Assist during regulatory agency inspections.
Requirements:
- Degree in a Life Sciences discipline.
- Previous experience as a Regulatory Affairs manager, ideally with significant experience in the regulatory submission and approval processes for new medicinal products.
- Effective verbal and written communication skills in order to keep other managers and department heads informed of regulations and policies that require compliance.
- Problem solving and strategic planning skills.
- An excellent level of English, both written and spoken, to enable the correct completion of reports and documentation required by regulatory authorities.
- Good interpersonal skills and able to work effectively both in cross-functional teams and independently.
- Attention to detail, and capacity to follow projects through to completion.
- Experience with CMC regulations for parenteral drug products.
We offer:
A contract and salary proportional to the experience of the successful candidate.
Job location:
Siena - Italy
Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address jobopportunities@philogen.it, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).