Sanofi Hiring
Officer - Regulatory Affairs Graduate/Post Graduate in Life sciences
(B.Tech/M.Tech (Bio Tech), M.Sc(Bio Tech / Bio Chem / Microbio)
[Authoring
of dossiers and Preparation of query response, Database update, Working on
e-tools]
- Authoring and 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 presentation, whilst meeting agreed deadlines.
- Work proactively with internal stake holders 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
utilisation of regulatory e-tools
- Provide
support transversally
- Maintain
and update all the relevant databases up-to-date
- Review of
artworks as per the labelling requirements
[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
]
- Graduate/Post
Graduate in Life sciences (B.Tech/M.Tech (Bio Tech), M.Sc(Bio Tech / Bio Chem /
Microbio)
- · Minimum 2
- 4 years’ experience within Regulatory Affairs or in similar function in the
Vaccine or Biological industry with CMC and Industrial Operations experience is
preferred
- Demonstrated
experiences in international and local regulatory affairs on Vaccines or
Biological products
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