Industrial Regulatory Manager

Sanofi

Praha
Smlouva
Plný úvazek

Před 1 měsícem

Location: Prague
Hybrid
Job type: Temporary, 2 years Fixed Term Contract; Full time

About the jobAs an Industrial Regulatory Affairs Manager you will be part of EMG Gen Med Europe Quality & Regulatory department. It's the quality unit responsible for GxP oversight of Contract Manufacturing Organizations (CMOs) and business partners involved in the manufacture, testing, and transport of Sanofi products. EMG GenMed Europe staff interact with functional units within EMG, Sanofi sites, and other organizations within the industrial network (e.g. procurement, supply chain, finance) to ensure compliance with internal and regulatory requirements, and to disposition intermediate (e.g. API, drug substance) and finished products with minimal risk to quality or product supply. EMG GenMed Europe has responsibility for CMO activities related to GenMed product.Key responsibilities:

As a regulatory portfolio owner of established products, is accountable for maintenance of the existing portfolio with a worldwide scope, for processes starting from preparation to the dispatch to affiliates on time
Authors, reviews, approves and/or prepares the CMC documents and additional documents (CTDs, etc.) required for regulatory files
Follows the submission and approval of variations
Performs change control regulatory assessments and manages assigned action items
Provides regulatory advice outside of Regulatory Affairs
Prepare efficiently responses to enquiries and deficiencies noted by regulatory authorities in connection with applications filed
Ensures the regulatory support and manages the CMC-Regulatory activities for site transfer
Support activities to ensure regulatory compliance, identifying, highlighting and resolving gaps when applicable
Communicate with supply chain & quality to ensure regulatory strategy is implemented within agreed timeframes to achieve an uninterrupted supply of compliant product to the market
Participates on project teams and communicates status to respective Regulatory Affairs members
Uses time management skills to successfully meet deliverables. Anticipates delays in pre-defined submissions and either sets up corrective actions plan or proposes alternative solutions
Participate and/or provide support to GQA audits and preparation as well as CMO GMP inspections if needed
Manages contacts among third parties where CMC related issues/topics are concerned, relevant functions within Industrial Affairs, and project teams. Sets up necessary meetings among all parties, and negotiate issues between parties as needed
Provides input and resources towards the development and implementation of new Regulatory systems, procedures, and/or tools
Responsible for staying up-to-date on regulatory guidances and technical/scientific developments

About YouExperience:

5+ years of Regulatory CMC experience is strongly preferred
Minimum of 2 years prior Manufacturing or Quality Assurance experience in the pharmaceutical/biotech industry

Technical skills:

Authoring of Regulatory dossiers (Module 3 Quality, Module 2)
In-depth knowledge and understanding of CMC topics, as well as North American, European and International regulations/guidelines, is strongly preferred
Demonstrated knowledge in QC

Soft Skills:

Ability to manage multiple priorities efficiently is strongly preferred

Languages:

Fluent in English

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, disability, or gender identity.Watch our and check out our Diversity Equity and Inclusion actions at !Discover our , that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document, before applying.#LI-EUR#LI-HYBRID#LI-REMOTEAt 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.

Sanofi

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