Regulatory Responsible

Regulatory Responsible

The position holder is accountable to lead CMC (Chemistry Manufacturing and Control) activities inside of the regulatory team reporting directly to the Team Leader. 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 linked to the dedicated portfolio and a key part of business and innovation.

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

• 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:
  • 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, demonstrating attention to detail and great rigour.

• Technical skills:
  • Knowledge of national and international current drug regulations (incl. EU, FDA, ICH, China).
  • Knowledge in Veeva Vault RIM and Veeva Vault Quality would be a plus.

• 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.