Sanofi Analyst Job For Life Sciences, Apply Online
Sanofi Analyst Job For Life Sciences, Apply Online. Interested and eligible applicants can check out all of the details on the same below:
Job Title – Analyst Regulatory Affairs
Job ID – R2654603
Location – Hyderabad
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, whilst meeting agreed-on 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 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.
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 responses.
- Supports Site RSO/RPM’s with regard to 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, and ensure the target timelines are met.
- Handle requests, either internal or external, related to RA activities.
Knowledge, Skills & Competencies / Language –
- Ability to work in teams.
- Demonstrated capacity to take up additional tasks.
- Excellent communication and writing skills.
- Knowledge of Regulatory guidance.
- English proficiency, both oral and written.
- Multi-tasking ability.
- The candidate should have excellent interpersonal skills, and be a self-driven proactive individual with skills in organization, building working relationships and communication.
- Basic software knowledge is a must.
- Graduate/Postgraduate in Life sciences/Pharmacy.
- 2-6 years of experience within Regulatory Affairs or in a 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.
Requirements of the job
- This position requires thorough knowledge of vaccine manufacturing.
- This position requires the incumbent to be proactive in meeting the organization’s needs.
- This position will suit an individual who is able to operate with discretion and confidentiality about sensitive data.
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