Pharmacy Regulatory Affairs Job Vacancy @ Sanofi – Apply Online
Sanofi hiring pharmacy candidates. Pharmacy job opening 2022. M Pharma job opening 2022. Pharma job opening 2022. Regulatory Affairs job opening 2022. Candidates having graduate and postgraduate degrees in pharmacy may apply for the job opening at Sanofi. Check out all the details on the same below:
Job Title: Associate-Regulatory Affairs
Location: Medchal Mandal Telangana
- Graduate/Post Graduate in Life sciences, Pharmacy
- Minimum 1‐6 years’ 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.
Authoring of dossiers and Preparation of query response, Database update, Working on e‐tools
- Authoring of the regulatory 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 utilization of regulatory e‐tools.
- Provide support transversely.
- 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 Coordinates with cross-functional teams for gathering the required information /documents required for authoring the dossiers and query responses.
- Supports Site RSO/RPMs 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 and Multi‐tasking ability.
- Demonstrated capacity to take up additional tasks.
- Working knowledge of CMC/technical writing skills.
- Knowledge of regulatory guidance.
- English communication proficiency, both oral and written.
- 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 (Microsoft windows etc.) is a must. Experience of handling regulatory tools would be an advantage.
Requirements of the job
- This position requires thorough knowledge on vaccine manufacturing/testing.
- 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
- To comply with HSE compliance and Business Ethics throughout the job
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