Sanofi Biotech / Biochem & Microbiology Job – BTech/MTech/MSc Apply
Sanofi Biotech / Biochem & Microbiology Job – BTech/MTech/MSc Apply. Sanofi is hiring MSc/ BTech/ MTech Biotechnology / Biochemistry / Microbiology candidates with experience for Officer Regulatory Affairs vacancy. Interested and eligible candidates check out all of the details on the same below:
Job Title: Officer – Regulatory Affairs
Job ID: R2555288
Location: India – Hyderabad
[Authoring of dossiers as well as Preparation of query response, Database update, Working on e-tools]:
- Authoring and also reviewing of dossier: Ensure that all data supplied to the affiliates/regulatory authorities are of the highest quality possible in terms of both content and also presentation, whilst 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 as well as follow up of registration documentation required to affiliates/ regulatory authorities
- Proper utilisation of regulatory e-tools
- Provide support transversally
- Maintain and update all the relevant databases up-to-date
- Review of artworks based on the labelling requirements
[Self-Development and Other expectations]:
- Participates and also Coordinate with cross-functional teams for gathering the required info/ documents required for authoring the dossiers and also query response.
- Supports Site RSO/RPMs with regard Regulatory Gap assessments
- Supports Site project teams as well as external stakeholders as part of project execution
- Guarantee close collaboration with Quality and Process Improvement teams to ensure optimal processes and tools are developed and also implemented. Lead creation and revision of relevant SOPs and work instructions. Evaluate and improve processes for submissions as well as regulatory info
- 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, Abilities & Competencies/ Language]:
- Ability to work in the teams
- Demonstrated ability to take up added tasks
- Outstanding communication and also CTD writing skills
- Knowledge of Regulatory assistance
- English proficiency, both oral as well as written
- Multi-tasking ability
- The applicant ought to have outstanding interpersonal skills, be a self-driven proactive individual with skills in organization, building working relationships as well as communication.
- Basic software knowledge (Microsoft windows etc.) is must
- Graduate/Post Graduate in Life sciences (B.Tech/ M.Tech (Biotechnology), M.Sc( Bio Technology/ Bio Chem/ Microbio).
- Minimum 2 – 4 years’ experience within Regulatory Affairs or in a similar function in the Vaccine or Biological industry with CMC and Industrial Operations experience is favoured.
- Demonstrated experiences in international and local regulatory affairs on Vaccines or Biological products.
[Requirements of the job]:
- This position requires thorough knowledge of Vaccines making.
- This position requires the incumbent to be proactive in meeting the organization needs.
- This position will certainly suit an individual that is able to operate with discretion and also confidentiality regarding sensitive data.
- To comply with HSE compliance and also Business Ethics throughout the job.
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