Manufacturing and Supply
Wo Wunder der Wissenschaft
für Patient*innen Realität werden

Job Title: Head of Site Regulatory -Regulatory Site Office

Location: Framingham, MA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

The Quality Assurance Department is responsible for providing oversight on all GMP activities and related functions associated with the manufacture and release of biological products at the site.  The department manages the regulatory site program for the Framingham Biologics, Framingham Biosurgery and Northborough sites (e.g. Dossier Compliance, Dossier submission reivew) and provides site metrics to determine site performance against Quality Metric Indicators. The role manages a group of regulatory site officers with quality assurance and regulatory compliance background and expertise. These professionals work closely with other cross-functional teams including QA, QA Manufacturing, Engineering, MTS, Planning/Logistics) to provide guidance and expertise.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities

• Defining the potential regulatory impacts of changes made to the site products and services

• Managing the technical writing for the marketing applications of the site products. Author the variations, the CTD sections impacted by the changes, the renewals of the site products registrations in compliance with all applicable regulations and company processes

• Ensuring compliance of the site products with all relevant product registrations, laws, regulations, standards, and guidelines in the markets where the site operates. Decide and execute the regulatory compliance maintenance program for the site products

• Maintaining a system to ensure regulatory risks are properly identified, tracked and mitigated

• Providing the regulatory support during site inspections

• Monitoring the regulatory submissions and approvals for the site products and devices

• Monitoring and anticipating changes in the regulatory environment and determine the impact and implications for the site

• Developing and implementing regulatory procedures supporting the right operation of the activities

• Establishing metrics and monitor data for the regulatory performance, to identify trends and issues and to implement action plan

• Promoting a culture of quality throughout the site organization and ensuring a correct awareness of regulatory process applicable to the site products

• Leading and managing the regulatory team, including hiring, training, coaching, professional development and performance evaluation.

• Managing the writing of the Site master file

Leadership

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

• Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.

• Being honest and treating people with respect and courtesy.

• Constantly striving to make Sanofi a great place to work, and a company respected for the quality of its people and products.

• Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Leading People: Sanofi’s leaders motivate, inspire, build, and retain highly effective manufacturing teams while managing for high performance and developing others. They are versatile learners and courageous decision makers.

Leading the Business: Sanofi’s leaders are effective operating in an evolving, complex and dynamic environment, providing clear direction and instruction to direct reports, and continuously looking internally and externally for best practices and areas for improvement.

Delivering to Customers: Sanofi’s leaders understand patient and customer needs and build relationships as required to meet manufacturing goals while continuously improving operations by setting high standards for the team so they may perform to a level of excellence.

About You

Experience

• Bachelor’s degree in science/engineering or another technical field.

• 12 years of experience in Pharmaceuticals or a related industry or a MS in science or engineering and 10 years of experience Pharmaceuticals or a related industry.

• 8+ years in a management position, 8+ years specific in a quality role in a pharmaceutical or biotech organization.

• Significant knowledge and experience with FDA/EMA/TGA/HC regulations

• Proficient in computer software programs and applications.

• Effective communication skills (listening, verbal and written).

• Ability to collaborate across functions and throughout all levels.

• Demonstrated problem solving skills.

• Extensive experience in ensuring compliance with local, national, and international pharmaceutical regulations and standards.

• Proven experience of managing internal audits and hosting external regulatory inspections from health authorities, including preparation, execution, and follow-up

• A thorough knowledge and understanding of the pharmaceutical industry and the applicable laws, regulations, and standards

Skills

• In-depth understanding of pharmaceutical regulations, guidelines, and standards (e.g., FDA, EMA, ICH).

• Ability to analyze complex compliance issues, identify root causes, and develop effective solutions

• Strong verbal and written communication skills to effectively convey compliance requirements and updates to various stakeholders.

• Proficiency in managing multiple compliance projects simultaneously, ensuring timely completion and adherence to standards.

• Keen attention to detail to ensure accuracy in compliance documentation, audits, and reports.

Preferred Qualifications

• Understanding of Aseptic processing, use of SUT as a manufacturing platform, use of digital systems in manufacturing operations.

• Equipment and process validation in cGMP environment.

• Knowledge of Total Quality Management (TQM), ISO, Six-Sigma, etc.

Special Working Conditions

• Ability to gown and gain entry to controlled, classified areas

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.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.