Drug Regulatory Team Leader

Sanofi

Budapest, Hungary

The position holder is accountable to lead and coordiante CMC (Chemistry Manufacturing and Control) activities of his team, reporting directly to the Head of Regulatory Affairs. This position is essential to guarantee the supply continuity by maintaining the Marketing Authorization of our drug products and driving the regulatory strategy to faster the implementation in case of need. The position holder is the focal point for the CMC expertise for all projects in the dedicated cluster and a key part of business and innovation.

Main responsibilities

Team Management:
- Leads and coordinates the activities of the regulatory team by ensuring compliance with the processes defined within the group;
- Defines the objectives of his employees and ensures the evaluation and development interviews in accordance with the schedule defined by human resources;
- Provides operational support to regulatory managers for the drafting of regulatory dossiers (variations, answers to questions from health authorities…) and the evaluation of the most complex changes control.
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;
- Consolidates regulatory activities in a planning tool in liaison with other regulatory affairs functions.
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 control meetings;
- Follows the submissions and approvals of variation files in each country.
Regulatory Compliance:
- Ensures that the CMC dossier is in line with manufacturing and control procedures at the related CMO and with dossiers approved by Health Authorities;
- Evaluates the regulatory compliance of current dossiers versus manufacturing site practices and current regulations and highlights discrepancies.
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;
Monitor the quality indicators in place and participate in the continuous improvement program at the subcontractor level and within EM CHC.

About you

Experience:
- Practical experience in CMC writing and/or Regulatory Affairs business;
- Practical experience in pharmaceutical industry in GMP environment (Quality Assurance and Development or Production/Quality Control). Experience in establishing and maintaining GMP and regulatory compliance.
Soft skills:
- Leadership spirit, team management skills;
- Strong written and oral communication skills. Able to communicate effectively and efficiently with other functional departments in the business;
- Ability to work well within cross-functional teams;
- Ability to establish priorities and timelines to effectively manage workload;
- Ability to manage multiple priorities and shifting priorities efficiently;
- Self-motivated and well organised.
Technical skills:
- Knowledge of national and international current drug regulations (incl. EU, FDA, ICH);
- Knowledge in Veeva Vault RIM and Veeva Vault Quality.
Education:
- Scientific studies in pharmacy, Ph.D. in pharmaceutical sciences preferred, Chemical or biochemical engineer.
Languages:
- Good English language skills to effectively negotiate and communicate verbally and in writing;
- Any language skills in addition are preferred.