Principal Expert I, Regulatory Compliance, EVF
Sanofi is preparing its future through an ambitious program named Evolutive Facility (EVF). The EVF Project is at the cornerstone of Sanofi strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address business challenges. Digital will be one of the key topics to help EVF to reach its ambition. On top of it, Sanofi is also embarked with the ambition to leapfrog the competition through a digital acceleration program with the following vision: “Sanofi will fully integrate Digital capabilities & culture within its operations to boost business growth and profitability in 2025+”.
In this context, we are looking for one Principle Expert I, Regulatory Compliance for our new site based in Singapore.
The Regulatory Compliance function is under the remit of the Site Quality Department, and is responsible for supporting regulatory compliance for the manufactured drug substances by means of a fit-for-purpose and timely handling of all site regulatory activities. The Principle Expert, Regulatory Compliance will work with Global Regulatory CMC on the product filing strategy to the world-wide markets, and support and/or author the relevant sections of the product registration dossier. In addition, the position will manage regulatory activities linked to change controls including updating of CMC files, supporting product licenses maintenance and site registration, and assumes the role of regulatory expert for all regulatory topics and projects on the site.
The mission described below, must be exercised in compliance with health, safety and environment of the site rules.
- Position the drug substance filing and licence renewal strategy with Global Regulatory CMC team.
- Provide regulatory advice (US, EU, rest of markets etc) and support to site, facilitating the introduction of new products, process technologies and continuous improvement projects.
- Analyses complex regulatory issues and processes and applies own professional knowledge to identify key areas of risk to compliance with registered details.
- Plan, map and communicate regulatory activities/approvals to the Site Quality Head and various departments as required.
- Contributes to consultation for Health Authority interaction.
- Support batch release by following submission and approval to ensure the product regulatory compliance.
- Ensure the regulatory compliance maintenance so that records approved by health authorities are aligned with site operational documentation. Ensure compliance of CMC records with current regulations (ICH, Pharmacopoeias).
- Prepare and provide quality & regulatory documentation required, communicate directly with affiliates (e.g. QA, QC, MSAT) for these activities. Coordinate the despatch of the regulatory documents to Global Regulatory CMC for submission.
- Review and approves cGMP or regulatory reports / change controls / deviations / protocols / submissions and associated action plans in order to ensure regulatory and cGMP compliance.
- Contribute to regulatory intelligence on their specific field of competencies and communicates the appropriate information.
- Supports and coordinates sample and reference standards shipments to support licensure and Government release of the finished products.
- Contributes to on-site inspections and audits.
Education and experience
- Bachelor’s or Master’s Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life Sciences or Technology with at least 12 years of relevant experience working in the biopharmaceutical industry, and with at least 2 years of experience in areas such as regulatory dossier authoring and managing queries from the regulatory authorities.
Key technical competencies and soft skills:
- Good knowledge of US, EU, Japan and key Rest of the World (RoW) market regulatory requirements
- Solid knowledge of regulations and standards of the pharmaceutical industry
- Good foundational knowledge of biopharmaceutical manufacturing process or product testing operations and common analytical methods.
- Strong interpersonal relationships in order to establish the partnerships necessary for the development of the CMC dossier and quick turnaround of regulatory queries.
- Good communication skills in order to advocate site positions with the Global Regulatory CMC and MSAT functions, including during inspections
- Good understanding of risk-based decision framework
- Fluent in English speaking and writing
- Sound practitioner of Manufacturing 4.0 mindset (or equivalent Lean or Agile methodology)
- Experienced in start-ups or new product introduction will be advantageous
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.