Regulatory Affairs Officer

Regulatory Affairs Officer

Sanofi

Amsterdam, Netherlands

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Global Regulatory team as Regulatory Affairs Officer VIE and you’ll manage and conduct global regulatory activities for assigned projects in line with regulatory requirements. You will also provide operational support as needed on the different indications in development by preparing, compiling, reviewing and processing the regulatory submissions for activities such as IND, CTA, scientific advice, paediatric investigation plans (PIPs)/Pediatric Study Plans (PSPs), amendments, response documents, study protocols, study reports, investigator brochures, safety reports, etc.

Main responsibilities

• Coordinating and consulting with other concerned functions and the RS and GRL on the content, and assembly of regulatory documentation and ensuring consistency, completeness, and adherence to standards for all the regulatory submissions;
• Attending and participating in the regulatory and cross-functional project teams, providing clear and consistent regulatory recommendations;
• Assist with regulatory communications with the Health Authorities where needed, including generation of responses to Health Authority queries;
• Track regulatory project status and informational documents;
• Coordinate required documentation with partners (e.g. CMC Team) or functional groups;
• Support operational and compliance activities for assigned deliverables, develop, generate, execute and maintain submission content plans, submission tracking, and document management utilizing the support and input of cross-functional team where relevant.

About you

Experience:

• Industry experience with regulatory affairs preferred (for instance experience in regulatory operations and coordination of regulatory documents, as well as with the preparation of regulatory submissions).

Technical and soft skills:

• Fundamental knowledge to compare documents with Health Authority standards;
• Ability to produce written and oral regulatory or scientific communications with clarity, accuracy and rigor, and to understand scientific subject matters as well as the evolving regulatory policy and guidance;
• Ability to evaluate the impact of the regulations on drug development;
• Understanding of the pharmaceutical industry, drug development environment, knowledge of local and global pharmaceutical and health-related regulations and requirements (i.e. ICH, FDA, EU, etc.);
• Ability to have a rapid and solid expertise in electronic document management systems (e.g. Veeva vault, Plai), with a great interest in AI;
• Ability to work in a fast paced environment, with cross-functional teams, by managing multiple tasks simultaneously.

Education:

• Physician, Pharmacist, Veterinarian or Life Sciences Master’s Degree preferred.

Languages:

• Fluent in English.

Apply NowDeadline 22 September