Regulatory Affairs Officer
We are seeking for a regulatory affairs officer to sign up for our regulatory affairs team.
Our organization, a pharmaceutical laboratory with the qualification of operator and importer, features a large variety of solutions in the health field to other national or global pharmaceutical laboratories.
Non-exhaustive missions:
Carry out all activities connected to the registration and servicing of the internet marketing authorization in accordance with the legislation.
Assist the Director of Regulatory Affairs
Coordinate the management and articles of the registration files with our suppliers
Administration of a product portfolio
Drafting of the administrative and / or pharmaceutical element of the registration strategies
Submission of the registration documents to the proficient authorities
Stick to-up of registration files, respond to to queries from authorities
Drafting, checking and / or assessment of alter and renewal tactics
Drafting, presentation and checking of technological and healthcare-economic procedures (with CEPS and HAS)
Auditing of pharmaceutical information
Preparation, submission and adhere to-up of CEP data files to the EDQM or ASMF / DMF to the capable worldwide authorities
Publishing of eCTDs (any kind of file, any form of course of action)
Drafting and updating of methods relating to regulatory affairs
Speak to with associates for all inquiries relevant to regulatory affairs
Regulatory and scientific checking.
Experiences and high-quality:
Learn II in Regulatory Affairs
Minimal 5 months in regulatory affairs
Minimum amount amount of French and English B2
Place to be stuffed swiftly.
Style of function: Work-review, Internship
Position body
Positive aspects:
Participation in transport
Fantastic meal
Programming:
From Monday to Friday
Day perform
Kinds of bonuses and bonuses:
13th thirty day period
Coaching:
Bac +5 (Learn / MBA) (optional)
Knowledge:
regulatory affairs: 1 yr (optional)
Tongue:
English (necessary)
Envisioned start off date: 09/19/2022
–
