REGULATORY AFFAIRS MANAGER
Philogen
siena
20
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Azienda: Philogen siena
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, IN Ds) 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 (SO Ps) 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:
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).
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✔ Philogen