Job title: Head of Regulatory Affairs (CMC) Services

• 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.

The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing avital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines.

Main responsibilities:
• Lead and manage the global technical writing activities, ensuring alignment with global strategies and objectives
• Oversee the quality, external manufacturing and supply, manufacturing science and technology and global device packaging unit technical writing teams, supervised by team managers
• Develop and implement strategic plans for the global technical writing hub, focusing on continuous improvement and operational efficiency
• Align activities with requirements and needs of the global M&S organizations, global policies, standards, and regulatory requirements
• Monitor key performance indicators (KPIs) and ensure that teams meet or exceed targets.
• Ensure that all global technical writing comply with established internal quality standards defined by the global M&S team and external regulatory requirements
• Foster a culture of continuous improvement, professional development, and teamwork within the global hub
• Act as the primary interface between the global hub and business operations, ensuring effective communication and collaboration
• Maintain strong relationships with internal and external stakeholders to facilitate smooth technical writing processes.
• Manage global resources effectively, ensuring that teams have the necessary tools, training, and support to perform their roles and identify and address resource gaps to optimize team performance
• Drive continuous improvement initiatives within the global hub, leveraging feedback and best practices to enhance processes and outcomes
• Stay updated on industry trends to ensure the hub's activities remain compliant and cutting-edge.

About you

Experience:

• 8 plus years professional experience in technical writing and proven multinationalleadership track record.
  

Soft skills:

• Proficient in problem-solving, attention to detail, and good organizational skills.
  
• Abilityto work collaboratively with cross-functional teams in a flexible and proactive manner.
  
• Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments.
  

Technical skills:

• Excellent technical/scientific writing skills and knowledge of statistical analytics.
  
• Proven experience in regulatory document preparation, CMC submissions and interaction withHealth Authorities. Theoretical knowledge in Chemistry Manufacturing & Control (CMC),biotechnological manufacturing operations (for VX & SPC only), Regulatory Registration andMaintenance, GxP and health-related regulations. 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)
  

Education:

Advanced degree (e.g., PhD) in Pharmacy or Chemical/Bio-Chemical Engineering

Languages:

Excellent communication skills in English spoken and written.

Why choose us?

Bring the miracles of science to life alongside a supportive, future-focused team.

Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.

Be part of an international collaborative team

• Work for several sites and varied departments
  
• Be involved in crucial statistical activities for the company like in the regulatory dossiers.