Regulatory Operations Intern: Data, Submissions & Compliance

Ompharma

Genf

Híbrido

CHF 21.000 - 27.000

Jornada completa

Hace 5 días
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Paid internship

Descripción de la vacante

OM Pharma invites applications for a paid Regulatory Affairs Operations Trainee position based in Meyrin, Geneva, CH. The internship supports regulatory data management, dossier maintenance and electronic submissions, under supervision of the RA Team Lead.

You will gain hands-on experience in international regulatory operations, learn about health authority submissions, and collaborate with internal teams and external partners in a multicultural setting.

Formación

  • Currently pursuing a Bachelor or Master’s degree in Life Sciences, Pharmacy, Regulatory Affairs, Health Sciences or a related scientific discipline.
  • Strong interest in pharmaceutical regulatory affairs, regulatory operations and regulatory data management.
  • Comfortable using databases, document management systems and Microsoft Office tools; previous exposure to Veeva an asset.
  • Strong written and spoken English skills (minimum B2 level); additional knowledge of French and/or Spanish is an advantage.

Responsabilidades

  • Support day-to-day regulatory operations activities and assigned regulatory projects, ensuring accurate documentation and timely follow-up of deliverables.
  • Maintain and update product and registration information in regulatory databases and systems.
  • Review regulatory data to ensure accuracy, consistency, and completeness.
  • Archive regulatory documents, correspondence and submission packages in accordance with internal procedures.
  • Assist with the preparation, compilation and technical review of electronic submission packages for health authorities.
  • Contribute to the management and maintenance of product information and regulatory data used for health authority submissions.
  • Collaborate with internal stakeholders and partner companies to collect, verify and update regulatory documentation and data.
  • Help track regulatory submissions and project progress using tracking tools and status reports.
  • Keep up to date with relevant regulatory requirements, procedures and operational best practices.

Conocimientos

Regulatory data management
Regulatory operations
Microsoft Office
Veeva (asset)
English proficiency (B2+)
French/Spanish knowledge (advantage)

Educación

Life Sciences/Pharmacy Regulation degree

Herramientas

Regulatory databases
Document management systems
Veeva (asset)

Descripción del empleo

OM Pharma invites applications for a paid Regulatory Affairs Operations Trainee position based in Meyrin, Geneva, CH. The internship supports regulatory data management, dossier maintenance and electronic submissions, under supervision of the RA Team Lead.

You will gain hands-on experience in international regulatory operations, learn about health authority submissions, and collaborate with internal teams and external partners in a multicultural setting.

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