External Job Description
Job title: Regulatory Affairs (CMC) Writer
- Location: Hyderabad
Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions.
As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health.
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The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams in the area of regulatory compliance, maintenance of product licenses and technical writing of CMC documents. The team members of the global M&S Services Hub will act as partners in carrying out tasks and fulfilling responsibilities to support global external manufacturing & supply activities with a focus on technical writing.
Ready to push the limits of what's possible? Join Sanofi and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.
Main responsibilities:
- Regulatory Intelligence & Requirements- Communicate to sites the information on new regulations. List the CMC changes required on the CMC documentation impacted by the new CMC regulations. Oversees the implementation of new regulations with sites
- CMC Document Management- Identify & collect the supportive data, statements from CMO. Write CMC regulatory dossiers for single non-complex changes, Renewals and CMC Document writing incl. SCP/eTOC preparation/filling for Renewals and Annual report
- Report issues in implementing quality technical writing processes to ICM Regulatory Compliance- Support sites in the regulatory compliance maintenance by sourcing and compiling the latest CMC dossiers and Post-Approval Changes from the company databases. Track the due dates for Site registration and oversee progress by sites. Check and approve the product designation across manufacturing and regulatory.
- Transversal Activities- Perform local training for sites to CMC regulatory requirements and IT tools. Contribute to Global Quality reporting (KPIs) . Focal point for 3rd party customer regulatory request
- Experience: min. 3 years of experience in CMC regulatory affairs (Worldwide regulations knowledge), as well as experience in a transversal position within a global company interacting with multiple functions/countries. Experience in pharmaceutical manufacturing or testing activities is appreciated.
- Soft skills and Technical skills: Proficient in problem-solving, attention to detail, and good organizational skills. Ability to work collaboratively with cross-functional teams in a flexible and proactive manner. Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments. Theoretical knowledge inChemistryManufacturing& Control (CMC), aseptic processing, validation principles, quality control techniques. Regulatory Registration andMaintenance,GxPandhealth-relatedregulations. Abilityinwriting technical documents and reports, good organization and planning skills, sense ofpriorities and teamwork ability and cooperatetransversally
- Education: Pharmacist or Chemical/BiochemicalEngineer having strong regulatory knowledge (CMC), in biotech and vaccine regulations
- Languages: Verbal and written fluency in English