Job title: Regulatory Affairs (CMC) Lead - MSAT & GDPU
Location: Hyderabad
Job type: Permanent, Full time
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 in the area of medical device and drug device combination products development and maintenance, as well as supporting global manufacturing sciences, analytics, and technology activities with a focus on technical writing.
We are seeking a highly skilled and motivated Technical Writing - MSAT & GDPU Team Lead to provide strategic direction and leadership to our technical writing team. The ideal candidate will have a strong engineering background with significant experience in technical writing, medical device development, drug device combination products, and validation report creation.
Act as the primary interface between the technical writing team and the global M&S organizations
GDPU and MSAT, ensuring effective communication and collaboration.
Provide strategic direction to the technical writing team, aligning activities with GDPU and MSAT 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
Minimum 5 years of experience in medical device and pharmaceutical industry as well as proven leadership track record.
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
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.
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!