Job title: Regulatory Affairs (CMC) Lead
Location: Hyderabad
Job type: Permanent, Full time

About the job

Our Team:

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.

• Act as the primary interface between the technical writing team and the global M&S organizations, ensuring effective communication and collaboration.
  
• Provide strategic direction to the technical writing team, aligning activities with the requirements and needs, company goals and regulatory requirements.
  
• Oversee daily operations of technical writing activities, ensuring timely and accurate completion of tasks and prioritize activities when needed to deliver company business needs.
  
• Drive continuous improvement initiatives within the technical writing processes and methodologies.
  
• Mentor, coach, and develop team members, conducting performance evaluations and facilitating professional growth.
  
• Act as the liaison between the technical writing team and the global hub leadership team, ensuring alignment and effective communication.
  
• Ensure strict compliance with internal and external regulations and guidelines related to technical writing and documentation.
  
• Oversee the preparation, review, and approval of technical documents, validation reports, and regulatory submissions, ensuring accuracy and completeness.
  
• Ensure that the technical writing team has the necessary tools and training to perform its tasks.
  
• Maintain collaborative relationships with key stakeholders to ensure smooth execution of technical writing activities.
  
• Support communication and stakeholder management plans, coordinating core and extended team activities.
  
• Implement effective risk management practices and ensure timely tracking of project activities against schedule and cost parameters
  

• 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
  

• Proven experience in regulatory document preparation, CMC submissions and
  
• interaction with Health Authorities.
  
• Ability in writing technical documents and reports, good
  
• organization and planning skills, sense of priorities and teamwork ability and
  
• cooperate transversally.
  
• In-depth knowledge of DHF compilation/maintenance/remediation, device risk management, and change control.
  
• Familiarity with medical device and drug device combination products regulations and standards (21 CFR 820, ISO 13485 and ISO 14971).
  
• Knowledge of medical device technical standards is preferred (ISO 11040, ISO 11608, ISO 10993) Excellent technical/scientific writing skills and knowledge of statistical analytics.
  

• Pharmacist or Chemical/Bio-Chemical Engineer having strong regulatory knowledge
  
• Advanced degree (e.g., PhD) is preferred
  

• Verbal and written fluency in English