Get AI-powered advice on this job and more exclusive features.
Direct message the job poster from Besins Healthcare
Recruitment Officer at Besins Healthcare
About Us
We are a pioneering, family-owned pharmaceutical company dedicated to advancing the development and global commercialization of reproductive hormone therapies that support the lifelong health and well-being of both men and women.
Our products are widely used in gynaecology, fertility, obstetrics, and endocrinology.
With presence in over 90 countries through a strong network of subsidiaries and distributors, we continue to grow sustainably.
Today, we operate with approximately 1,500 employees, 22 subsidiaries, and 5 manufacturing sites. Our continued success is built on attracting exceptional talent and fostering a collaborative, growth-focused environment.
Position
Participate in department's Reg CMC activities, for a portfolio of products intended for international markets by acting as interface between the industrial production sites and CMC regulatory department.
Key Responsabilities :
* Acts as the interface between the manufacturing sites and CMC regulatory to collect the documents for registration (batch record, CoA API & excipients, QP declaration, statement, etc..); Facilitate the process with the site
* Follow up of the ICH and commercial stability (update stability tracker, report OOT or OOS results to Reg CMC team, stability trend analyses)
* Compilation and review of the documents require for local GMP certification worldwide and renewals (Application form, GMP, ML, SMF, PQR, layout, inspection reports etc..)
* Check the regulatory (gap analysis dossier versus industrial) compliance of the pharmaceutical dossier with regard to industrial documentation
* Review and validation of protocol and reports related to M3
* Create, review and follow-up the Change Control related to the industrial parts of the production sites
* Review of documents (ex : batch record templates, reports, etc..) to check compliance with registered dossier
Job Requirements:
Level of experience, qualifications, know-how and behavioural
Team player
Ability to multi-task
Ability to communicate with colleagues in global countries
Seniority level
* Seniority levelMid-Senior level
Employment type
* Employment typeFull-time
Job function
* Job functionManufacturing
* IndustriesPharmaceutical Manufacturing
Referrals increase your chances of interviewing at Besins Healthcare by 2x
Sign in to set job alerts for “Regulatory Affairs Officer” roles.
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr