Sanofi Life Science Officer Recruitment – Applications Invited
Sanofi Life Science Officer Recruitment – Applications Invited. Sanofi is hiring MSc /BSc Life Science candidates with experience for Officer vacancy. Interested and eligible candidates check out all of the details on the same below:
Job Title: Officer
Job ID: R2576178
Location: Hyderabad
[Authoring of dossiers and also Preparation of query response, Database update, Working on e‐tools]
- Authoring and reviewing of the dossier: Guarantee 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.
- Work proactively with internal stakeholders to ensure project needs are met compliantly within agreed timelines
- Aid as well as 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 pertinent databases up‐to‐date consisting of Post License commitments
- Review of artworks according to the labelling requirements
[Self‐Development as well as Other expectations]:
- Participates as well as Coordinate with cross-functional teams for gathering the required information/ documents required for authoring the dossiers as well as query response.
- Supports Site RSO/RPMs with regard to Regulatory Gap assessments
- Supports Site project teams and also external stakeholders as part of project execution
- Ensure close collaboration with Quality and also Process Improvement teams to guarantee optimal processes and also tools are developed and also implemented. Lead creation and also a revision of relevant SOPs and also work instructions. Evaluate and enhance processes for submissions and also 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, guarantee the target timelines are met.
- Handle requests, either internal or external, related to RA activities.
[Transversal Cooperation]:
- Health Authority (HA), Commitments & Documents: Responsible for arranging timely as well as accurate tracking of regulatory authority requests as well as commitments related to approvals.
- Inspection Preparation/Support and also timely submission of CAPA as well as other submissions related to Regulatory compliance.
- To actively involve in understanding and submission of various applications to CDSCO (in SUGAM) and SLA (ODLS) websites.
[Knowledge, Abilities & Competencies/ Language]:
- Capability to work in the teams
- Demonstrated capacity to take up additional tasks
- Excellent communication and also CTD writing abilities
- Knowledge of regulatory guidance
- English proficiency, both oral and also written
- Multi‐tasking ability
- Candidate must have excellent social abilities, be a self‐driven proactive individual with skills in organization, building working relationships and communication.
- Basic software knowledge (Microsoft windows etc.) is have to
[Qualifications]:
- Graduate/Post Grad in Life sciences
- Minimum 1‐6 years’ experience within Regulatory Affairs or in a similar function in the Vaccine or Biological industry with CMC and also Industrial Operations experience is favoured
- Demonstrated experiences in international as well as local regulatory affairs on Vaccines or Biological products
[Requirements of the job]
- 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 that is able to operate with discretion as well as confidentiality concerning sensitive data
- To comply with HSE compliance and also Business Ethics throughout the job
Apply Online
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