REGULATORY AFFAIRS MANAGER

Location

Siena (SI) | Italy

Job description

Job Title: REGULATORY AFFAIRS MANAGER

Location: Siena - Italy

Department: Clinical

REGULATORY AFFAIRS MANAGER

Philogen would like to hire a Regulatory Affairs Manager who will report to the Management 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.

In particular, the selected candidate will carry out the following tasks:

• 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
  • Reviewing draft registration files and submitting new and amended registration dossiers to obtain and maintain registration
• 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;
• Management of procedures related to Marketing Authorisation Applications for EMA and FDA;
• Managing 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 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;
• Preferably experience of but definitely an awareness of the key electronic submission tools

Requirements:

• University degree in science (preferred)
• 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.

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 [email protected], 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).

Job tags

Salary