Regulatory Expert

Budapest

About the job

As Regulatory Expert, you will be responsible for leading Chemistry, Manufacturing, and Control (CMC) activities within the regulatory team, reporting directly to the Team Leader. This role is crucial to ensure continuous supply by upholding the Marketing Authorization of our drug products and propelling the regulatory strategy to expedite implementation when necessary. The incumbent serves as the central point of contact for CMC expertise across all projects associated with the assigned portfolio and is a vital contributor to business operations and innovation initiatives

At Sanofi Consumer Healthcare, we build trusted and loved brands that connect with hundreds of millions of consumers worldwide. Our mission is to enable better self-care for individuals and communities, while also contributing to a healthier planet. We strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view. To achieve this, we need people who can shape the future of our business and help us on our journey to becoming the best fast-moving consumer healthcare company in and for the world

Main responsibilities:

CMC Documentation management

• Writes, updates and / or reviews CMC regulatory documents/dossiers to be dispatched to regulatory affairs functions for submission.

• Coordinates CMC writing performed by another entity (internal or external).

• Optimizes the content of CMC dossiers to facilitate the management of future changes by checking the relevant level of information to be provided.

• Prepares with contribution of CMO experts the answers to questions from Health Authorities

• Supports Marketing Authorisations worldwide (territory extensions, renewals, site registrations and transfers…) by writing and / or reviewing the corresponding CMC documents/dossiers and collecting GMP related documents.

Change Control

• Evaluates the regulatory impacts of changes during the product life cycle in accordance with the Change Control procedure in force.

• Defines the regulatory strategy and participate in change controls meetings.

• Follows the submissions and approvals of variation files in each country.

Regulatory Compliance

• Ensures that the CMC dossier is in line with the manufacturing and control procedures at the related CMO.

• Evaluates the regulatory compliance of current dossiers versus manufacturing site practices and current regulations and highlights discrepancies.

• Ensures the definition of corrective actions for gap closure.

• Acts as the regulatory interface with Global Regulatory Affairs or with Affiliate Regulatory Affairs for EM CHC.

• Supports business unit in the assigned region in the management of new business opportunities and product launches.

About you

• Your extensive practical experience in CMC writing, Regulatory Affairs, and GMP environments ensures compliance and quality within the pharmaceutical sector. 

• You exhibit strong communication abilities, both in writing and speaking, which facilitate smooth interactions across various business units. 

• Skilled in collaborating with cross-functional teams, you prioritize effectively and manage a varied workload with efficiency. 

• Your self-driven nature and organizational prowess are apparent in your meticulous and methodical approach. 

• You possess a thorough knowledge of drug regulations in key markets, including the EU, FDA, ICH, and China, and your acquaintance with Veeva Vault systems is advantageous. 

• Your academic qualifications in pharmacy, ideally with a Ph.D. in pharmaceutical sciences or as a chemical/biochemical engineer, enhance your technical acumen. 

• Additionally, your fluency in English and other languages bolsters your capacity to negotiate and communicate in an international arena.

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

Pursue Progress. 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 video and check out our Diversity Equity and Inclusion actions at sanofi.com