CAREERS

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).
 

Philogen S.p.A. is looking for a “GMP Quality Assurance Specialist” who will report to the GMP Quality Assurance Manager and who will give his/her contribution to quality policies in support of Philogen’s Quality System.
 
In particular the successful candidate will be responsible for:

• writing, reviewing and approving documents (SOPs, PQRs, IMPDs, validations, research reports, etc.);
• revision of production and quality control batch records;
• managing GMP QA operations, change control, deviation and documentation systems;
• identifying and recommending future improvements;
• implementing action plans;
• developing quality strategies and priorities and translating them into short and long-term objectives;
• risk assessment;
• interacting with other members of the company and clinical center staff.

 
The ideal candidate should have:

• A good scientific background (ideally in Biology, Biotechnology, etc.)
• Previous experience in Quality Assurance (at least three years);
• Comprehensive knowledge of GMP and other regulations with a good understanding of global quality standards relating to product development, submission and clinical experimentation;
• A high level of English language, both written and spoken;
• A high level of attention to detail and with the ability to prioritize working tasks;
• A strong flexibility in changing tasks and priorities;
• The ability to work independently as well as coordinate members of his/her team;
• Excellent interpersonal skills and ability to work in teams.

 
Job location:
Siena
 
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).
 

Philogen S.p.A. is accepting applications for the position of MEDICAL ADVISOR for the development of clinical experimental activity. The successful candidate will have the responsibility for supporting the management of Philogen’s clinical trials in oncology and rheumatology. 
 
In particular the successful candidate will be responsible for:
Collaborating with opinion-leaders and professional faculty to best design and implement clinical projects.
Providing support in designing and writing clinical portions of IND documentation including protocols, amendments, medical reports, safety and efficacy summaries, scientific rationales, interim and final reports.
Providing support in monitoring efficacy and safety trends by reviewing clinical data. Interacting with Principals Investigators and clinical site staff to advance the performance of clinical trials.
Interacting with regulatory agencies and clinical centres to support the Company’s development program.
Participating in Strategic Meetings.
 
The ideal candidate should have:
A degree in Medicine.
An excellent level of English, both written and spoken.
Good interpersonal skills
Ability to build trust and confidence in teams/departments
Ability to work independently.
 
 
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).