Regulatory Affairs Officer

Scienta; Île-de-France; On-site; EUR 42,000 - 56,000; Full time

Job summary

Scienta, a leading global consumer health business, is seeking a Regulatory Affairs Officer to join its international regulatory team in Île-de-France. You will support regulatory submissions, product registrations, and ongoing compliance across international markets, with a particular focus on Africa and emerging markets.

You will prepare, review, and maintain regulatory dossiers, ensure CTD Modules 2 and 3 alignment, and collaborate with internal departments and external partners to drive

Qualifications

• 1–3 years of Regulatory Affairs experience within the pharmaceutical, consumer health, or wider healthcare industry.
• Bachelor's degree in Pharmacy, Life Sciences, or a related scientific discipline.
• Experience supporting regulatory submissions, product registrations, variations, or renewals.

Responsibilities

• Prepare, submit, and maintain regulatory dossiers for pharmaceuticals, medical devices, cosmetics, food supplements, and biocides.
• Assist with regulatory submissions, variations, renewals, and product registrations across African and international markets.
• Prepare, review, and maintain regulatory documentation, including CTD Modules 2 and 3, ensuring compliance with local regulatory requirements.
• Support the regulatory review of product labelling, artwork, and associated documentation to ensure compliance with market-specific regulations.
• Collaborate with internal departments, local distributors, and external regulatory partners to support regulatory activities throughout the product lifecycle.

Skills

Regulatory affairs

Regulatory submissions

English fluency

Education

Bachelor's degree in Pharmacy/Life Sciences

Tools

CTD dossiers

Job description

We are partnering with a leading global consumer health business seeking a Regulatory Affairs Officer to join its growing international regulatory team. This position will support regulatory submissions, product registrations, and ongoing compliance activities across international markets, with a particular focus on Africa and emerging markets.

Key Responsibilities

• Support the preparation, submission, and maintenance of regulatory dossiers for pharmaceuticals, medical devices, cosmetics, food supplements, and biocides.
• Assist with regulatory submissions, variations, renewals, and product registrations across African and international markets.
• Prepare, review, and maintain regulatory documentation, including CTD Modules 2 and 3, ensuring compliance with local regulatory requirements.
• Support the regulatory review of product labelling, artwork, and associated documentation to ensure compliance with market-specific regulations.
• Collaborate with internal departments, local distributors, and external regulatory partners to support regulatory activities throughout the product lifecycle.

Key Requirements

• 1–3 years of Regulatory Affairs experience within the pharmaceutical, consumer health, or wider healthcare industry.
• Bachelor's degree in Pharmacy, Life Sciences, or a related scientific discipline.
• Experience supporting regulatory submissions, product registrations, variations, or renewals.
• Familiarity with CTD dossiers, regulatory documentation, and international regulatory requirements, ideally across emerging markets.
• Strong organisational skills, attention to detail, and excellent communication skills, with fluency in English.