Sanofi Job Opening for Regulatory Affairs (CMC) Lead -Apply Now
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.
The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines.
Main responsibilities:
- Act as the primary interface between the technical writing team and the global M&S organizations quality, ensuring effective communication and collaboration.
- Provide strategic direction and oversight to the quality technical writing team, ensuring alignment with quality 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 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 global hub leadership, ensuring 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 CMC regulatory dossiers, validation reports, and quality documents.
- 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.
About you
Experience:Â
- Minimum 4 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. Proven leadership track record required
Soft 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.
Technical skills:
- Theoretical knowledge in Chemistry Manufacturing & Control (CMC), aseptic processing, validation principles, quality control techniques Regulatory Registration and Maintenance, GxP and health-related regulations.
- Ability in writing technical documents and reports, good organization and planning skills, sense of priorities and teamwork ability and cooperate transversally
Education:
- Pharmacist or Chemical/Bio-Chemical Engineer having strong re ulatory knowledge (CMC).
- Advanced degree (e.g., PhD) preferred
Languages:
- Verbal and written fluency in English
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