Oncology Global Regulatory Specialist - VIE Contract (W/M)

Job description

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.

PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.

PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide.

Therefore, only applications that are submitted in English will be considered.

At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers.

We are looking for a candidate for a VIE mission of:

Oncology Global Regulatory Specialist - VIE Contract (W/M)

Job Description:

The Global Regulatory Affairs Oncology team provides leadership in support of new registrations or compliance of registered products. This team advises global project teams, contributes to the development and implementation of regulatory strategies in support of project objectives and assesses appropriateness of submissions to regulatory authorities to support successful clinical trial applications and marketing authorizations.

The Regulatory Specialist will support the Global Regulatory Team Leader in:
- Providing Global Regulatory Strategy in support of isatuximab programs

- Planning and tracking global regulatory submissions, Health Authority requests and team responses

- Supporting the compilation, development, submission and maintenance of worldwide regulatory filings

- Coordinating on the content and assembly of regulatory documentation as well as ensuring consistency, completeness and adherence to standards for all the regulatory submissions

- Preparing, reviewing and processing regulatory submissions including both pre-approval and submissions such as IND (Investigational New Drug), NDA (New Drug Application)/BLA (Biologics License Application), MAA (Marketing Authorization Application), amendments/supplements, annual reports, study protocols, investigator brochures, safety reports, etc.

- Tracking regulatory project status and informational documents

- Creating timelines to ensure that all submissions are submitted on-time

Candidate's profile:

A. Education: MA degree preferably in Pharmacy/Life Sciences or relevant field

B. Experience : minimum 1 year of full time experience in pharma industry, R&D (Research and Development), Regulatory Affairs or related functions

C. Soft skills :

- Excellent communication and organizational skills

- Self-starter with the ability to work independently but seeking out guidance if needed

- Strong interpersonal skills (collaborative, team-player, tactful and diplomatic)

D. IT tools :

- Knowledge of basic functions in Excel

- Proficiency in MS Word, PowerPoint; knowledge of MS Project is a plus

E. Languages : Fluent English, French would be a plus

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.