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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. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
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With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Job Description:
Authoring of dossiers and Preparation of query response, Database update, Working on e-tools
- Authoring and reviewing of the dossier: Ensure that all data supplied to the affiliates/regulatory authorities are of the highest quality possible in terms of both content and presentation, while meeting agreed deadlines.
- Work proactively with internal stakeholders to ensure project needs are met compliantly within agreed timelines
- Assist and provide support in the preparation, distribution and follow up of registration documentation required to affiliates/ regulatory authorities
- Proper utilization of regulatory e-tools
- Provide support transversally
- Maintain and update all the relevant databases up-to-date
- Review of artworks as per the labeling requirements
Self-Development and Other expectations
- Participates and Coordinate with cross-functional teams for gathering the required information /documents required for authoring the dossiers and query response.
- Supports Site RSO/RPMs with regard 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.
Knowledge, Skills & Competencies / Language
- Ability to work in the teams
- Demonstrated capacity to take up additional tasks
- Excellent communication and CTD writing skills
- Knowledge of regulatory guidance
- English proficiency, both oral and written
- Multi-tasking ability
- Candidate should have excellent interpersonal skills, be a self-driven proactive individual with skills in organization, building working relationships, and communication.
- Basic software knowledge (Microsoft windows etc.) is must
Qualifications:Â Graduate/Post Graduate in Life sciences (B.Tech/M.Tech (Bio Tech), M.Sc(Bio Tech / Bio Chem / Microbio)
Experience: Minimum 2 – 4 years’ experience within Regulatory Affairs or in a Similar function the Vaccine or Biological industry with CMC and Industrial Operations experience is preferred
Requirements of the job
- Demonstrated experiences in international and local regulatory affairs on Vaccines or Biological products
- This position requires thorough knowledge of Vaccines manufacturing.
- This position requires the incumbent to be proactive in meeting the organization needs
- This position will suit an individual who is able to operate with discretion and confidentiality about sensitive data
- To comply with HSE compliance and Business Ethics throughout the job
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