M&S - Regulatory Site Officer -IFB

About the job

Sanofi has decided to invest into a new large state-of-the art facility for Insulin Drug Substance in Beijing, China. For this green field operation, we’re enhancing our legacy of excellence and build on decades of expertise on the whole value chain of insulin manufacturing. The new facility will be designed as a fully automated, green, modern, and state-of-the-art biologics facility. A large global and highly cross-functional program organization will be established to lead and execute the program until commercial routine manufacturing.

Meet Katrin, our Global Program Leader, and discover how we’re transforming insulin production. Watch now!

Position Overview

The Regulatory Site Officer-IFB ensures compliance of Beijing insulin API products with all relevant product registrations, laws, regulations, standards, and guidelines, with focus on IFB China related requirements. This position supports authoring dossiers, variations, CTD sections impacted by changes, and renewals of product registrations in compliance with all applicable regulations and company processes. The role will coordinate with China country regulatory affairs&CMC regulatory, Global regulatory affairs&CMC regulatory-InsuLINK, support IFB regulatory strategy development, health authority interactions.

This role is expected to work independently and with a level of autonomy and authority in decision-making to ensure on-going compliance against approved documents and current Good Manufacturing Practices across the project during conceptional, basic and detailed design, construction C&Q, PQ, Validation and future site organizations until final approval.

Main responsibilities:

Core Regulatory Activities: 

• Ensures compliance of IFB insulin API products with relevant product registrations, laws, regulations, standards, and guidelines for assigned markets. 
• Authors and supports the creation of dossiers, variations, CTD sections impacted by changes, and renewals of IFB product registrations, with focus of local language regulatory documentation preparation following NMPA guidelines.
• Supports regulatory impact assessments of changes made to IFB products and services, mainly focus on China regulation and dossier impact assessment. 
• Assists in executing the regulatory compliance maintenance program for site products. 
• Monitors regulatory environment changes and supports impact analysis for IFB. 
• Supports regulatory aspects of product lifecycle management for IFB products. 
• Contributes to site master file writing and maintenance.
• Supports health authority interactions and responses to queries, contributes to health authorities reporting when applicable.

Quality and Project Support: 

• Actively participates in project work stream meetings, planning sessions, and regulatory deliverable coordination. Supports maintenance and reporting of regulatory performance metrics. 
• Provides regulatory support and documentation during site inspections.
• Supports quality systems implementation and GMP compliance. 
• Collaborate with quality teams to ensure regulatory-quality alignment. 
• Coordinate with Quality Regulatory InsuLINK to ensure alignment of regulatory strategy implementation across the InsuLINK program
• Contributes to C&Q&V strategy from regulatory and dossier impact assessment perspective,
• Supports quality culture and GMP compliance performance. 
• Provide regular reporting to IFB Quality Lead and have dotted line reporting to Lead RSO InsuLINK.

About you

Experience

• Degree in Science/Pharmacy or Equivalent.
• Ideally MSc level qualification in Science.
• 3-5 years industry experience, preferably within the biopharma and/or related regulated industry focus on Regulatory Affairs.
• In-depth knowledge of the BLA process, Annex 1 requirements, CTD format, and associated regulatory requirements in US, Europe and China.
• Strong technical regulatory writing skills and experience with health authority interactions.
• Knowledge of GMP and quality systems (supporting capability).
• Knowledge and experience in regulatory affairs for biologics, including regulatory strategy understanding and regulatory intelligence. 
• Experience with NMPA regulatory requirements. 
• Knowledge of Commissioning & Qualification, Process Validation Lifecycle, and Quality by Design principles (supporting knowledge). Scientific writing, effective oral and written communication skills, and innovative thinking. 
• Familiarity with strategic planning, balanced judgment and risk analysis. 
• Soft skills: Act for Change, Cooperate transversally, Decision making, People Development, Negotiation and Influential skills, Business Partnering, Communication skills (English), Leadership and assertiveness skills. undefined
• Technical skills: Regulatory intelligence and compliance systems, regulatory submissions management, CTD writing expertise, quality systems (supporting), Quality Risk Management, GxP and health regulated regulations, International and FDA exposure. undefined
• Languages: English (fluent), Chinese (fluent), 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.
• PursueProgress. Discover Extraordinary. 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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
• Watch our ALL IN videoand check out our Diversity Equity and Inclusion actions at sanofi.com!