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 thepeople we serve throughout the continuum of care. From prevention to treatment, Sanofi transformsscientificinnovationintohealthcaresolutions,inhumanvaccines,rarediseases,multiplesclerosis,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 isrecognized as one of the best pharmaceutical companies in the world and is pioneering the application ofArtificialIntelligence(AI)withstrongcommitmenttodevelopadvanceddatastandardstoincreasereusability & 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 andsupportingGlobalM&Steamsintheareaofmedicaldeviceanddrugdevicecombinationproductsdevelopmentandmaintenance,aswellassupportingglobalmanufacturingsciences,analytics,andtechnology activities with a focus on technical writing.

We are seeking a highly skilled and motivated Technical Writing- Team Lead to providestrategic direction and leadership to our technical writing team. The ideal candidate will have a strongengineering background with significant experience in technical writing, medical device development, drugdevice combination products, and validation report creation.

Main responsibilities:

• 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 teamactivities.

• Implement effective risk management practices and ensure timely tracking of project activities against schedule and cost parameters

About you

Experience:

Minimum 5years of experience inmedical device and pharmaceutical industryas well asproven leadership track record.

Softskills:

• Proficientin problem-solving, attention to detail, and good organizational skills. Abilityto work collaboratively with cross-functional teams in a flexible and proactive manner.

• Stronganalytical skills. Agile thinker and learner, adaptable to complex & dynamic environments

Technical skills:

• Proven experience in regulatory document preparation, CMC submissions and

• interactionwithHealthAuthorities.

• Abilityinwritingtechnicaldocumentsandreports,good

• organizationandplanningskills,senseofprioritiesandteamworkabilityand

• cooperatetransversally.

• In-depth knowledge of DHF compilation/maintenance/remediation, devicerisk management, and change control.

• Familiarity with medical device and drug device combinationproducts regulations and standards (21 CFR 820, ISO13485 and ISO 14971).

• Knowledge of medicaldevicetechnicalstandardsispreferred(ISO11040,ISO11608,ISO10993) Excellenttechnical/scientific writing skills and knowledge of statistical analytics.

Education:

• Pharmacist or Chemical/Bio-ChemicalEngineer having strong regulatory knowledge

• Advanced degree(e.g.,PhD) is preferred

Languages:

• 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!