Industrial Regulatory Affairs Officer

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 level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Manufacturing

• Industries

  Pharmaceutical 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.