Country: Hungary
Functional area: Regulatory Affairs

On behalf of our client, who is a global TOP innovative pharmaceutical company, we are searching for a CMC Regulatory Lead to join their affiliate in Hungary.

This position will be focusing on managing the regulatory team and will have a crucial role in coordinating the preparation of the DMF Modul III.

Responsibilities:

  • Managing the Regulatory team and advising on applicable regulatory requirements
  • Providing leadership, mentorship and supervision to his/her team to ensure transparency and alignment on strategic direction, goals, processes and objectives
  • Preparing, coordinating and maintaining Drug Master Files Module III
  • Preparing CMC responses to health authority questions during variation, registration and product lifecycle
  • Interacting and effectively communicating with other internal and external colleagues
  • Helping define CMC content (data and documentation) requirements for regulatory submissions and reviewing this content for conformance with established requirements.
  • Responsible for archiving of regulatory files and documentation, and maintenance of regulatory databases and manage all updates
Requirements:
  • MS degree in Pharmaceutics, Chemistry, Chemical Engineering is required
  • A minimum of 10 years of work experience in the CMC regulatory field
  • Strong knowledge of cGMP
  • Capability to lead and maintain a team
  • Excellent knowledge of English (oral and written)
  • Strong communication and negotiation skills, proven experience in interactions with internal and external stakeholders
Should you be interested in the details of this vacancy feel free to leave a comment with your details or submit your CV for this role.

On behalf of our client, who is a global TOP innovative pharmaceutical company, we are searching for a CMC Regulatory Lead to join their affiliate in Hungary.

This position will be focusing on managing the regulatory team and will have a crucial role in coordinating the preparation of the DMF Modul III.

Responsibilities:

  • Managing the Regulatory team and advising on applicable regulatory requirements
  • Providing leadership, mentorship and supervision to his/her team to ensure transparency and alignment on strategic direction, goals, processes and objectives
  • Preparing, coordinating and maintaining Drug Master Files Module III
  • Preparing CMC responses to health authority questions during variation, registration and product lifecycle
  • Interacting and effectively communicating with other internal and external colleagues
  • Helping define CMC content (data and documentation) requirements for regulatory submissions and reviewing this content for conformance with established requirements.
  • Responsible for archiving of regulatory files and documentation, and maintenance of regulatory databases and manage all updates 

Requirements: 

  • MS degree in Pharmaceutics, Chemistry, Chemical Engineering is required
  • A minimum of 10 years of work experience in the CMC regulatory field
  • Strong knowledge of cGMP
  • Capability to lead and maintain a team
  • Excellent knowledge of English (oral and written)
  • Strong communication and negotiation skills, proven experience in interactions with internal and external stakeholders

Should you be interested in the details of this vacancy feel free to leave a comment with your details or submit your CV for this role.Regulatory CTD English CMC