Authoring of dossiers and Preparation of query response, Database update, Working on e‐tools
· Authoring of 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 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 transversely.
· 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 Coordinate with cross functional teams for gathering the required information /documents required for authoring the dossiers and query response.
· Supports Site RSO/RPMs with regard 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, ensure the target timelines are met.
· Handle requests, either internal or external, related to RA activities.
Knowledge, Skills & Competencies / Language
· Ability to work in the 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.
· 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. Experience of handing regulatory tools would be an advantage.
Requirements of the job
· This position requires through knowledge on Vaccines manufacturing/testing.
· This position requires the incumbent to be proactive in meeting the organization 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
· Graduate/Post Graduate in Life sciences, Pharmacy
· Minimum 1‐6 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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.