Sanofi Associate Regulatory Affairs Post Vacancy – Apply Online
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain, and ease suffering. Check out all the details
Job Title: Associate Regulatory Affairs
Qualifications
- Graduate/Post Graduate in Lifesciences, Pharmacy.
- Minimum 2 maximum 5years’ of experience within Regulatory Affairs or in a similar function in the Vaccineor Biological industry with CMCand/orIndustrialOperationsexperience is preferred.
- Demonstrated experiences in international or local regulatory affairs on Vaccines or Biological products.
Authoring of dossiers and Preparation of query response, Database update, Working on e‐tools
- Authoring of the regulatory dossier: Ensure that all data supplied to the affiliates/regulatory authorities are of the highest quality possible in terms of both content and presentation, whilst meeting agreed-on deadlines.
- Workproactivelywithinternalstakeholders to ensure project needs are met compliantly within agreed timelines.
- Assistandprovidesupportin the preparation, distribution, and follow-up of registration documentation required to affiliates/ regulatory authorities.
- Proper utilization of regulatory tools.
- Provide support transversely.
- Maintain and update all the relevant databases to date.
- Review of artworks as per the labeling requirements.
Self‐Development and Other expectations
- Participates and Coordinates with cross-functional teams for gathering the required information/documents required for authoring the dossiers and query response.
Supports SiteRSO/RPMswithregard Regulatory Gap assessments. - Supports Site project teams and external stakeholders as part of project execution.
- Ensure close collaboration with quality and Process Improvement teams to ensure optimal processes and tools are developed and implemented. Lead creation and revision of relevant SOPs and work instructions. Evaluate and improve processes for submissions and regulatory information.
- Understanding of change Controls.
- Act as a Team member.
- Active participation in meeting the targets.
- To update the knowledge from time to time for effective delivery.
- Follow up with cross-functional teams, ensure the target timelines are met.
- Handle requests, either internal or external, related to RA activities.
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