Head of Regulatory Operations

Our client is a Pharmaceutical manufacturer and distributor of a broad range of licensed products through a third party network. They currently have an opportunity for a Head of Regulatory Operations.

Responsible for all communications to Regulatory Authorities including regulatory submissions. You will ensure that the content of regulatory submissions are of the appropriate standard to be approved. Responsible for the timely delivery of appropriate quality submissions and you will represent the Department at project team and other meetings requiring Regulatory submission guidance and strategy input.

Responsibilities:

• Manages all communications with Regulatory Authorities and ensures an appropriate tracking system is in place and maintained
• Deputises for the Director of Regulatory Affairs, as appropriate
• Manages the creation and submission of regulatory dossiers across regions according to local requirements and to agreed timelines
• Ensures that the contents and format of dossiers conform to internal and external guidelines and regulations, identifying deficiencies requiring further resolution and ensures appropriate actions taken
• Ensures the Company is up to date on changes to guidelines regarding submissions and provides advice to employees within Regulatory and various associated departments
• Ensures that systems are in place such that regulatory submissions and Marketing Authorisations are complete, technically accurate and comply with relevant guidelines
• Manage the compilation of dossiers for internal review and submission (publishing MAA's, MA Variations, PSURs, Renewals)
• Recommend and develop operational process improvements.

• Min 8 years experience in Regulatory Operations or equivalent in the Pharmaceuticals industry
• Thorough understanding of the Regulatory Operations area, including process and technology solutions
• Previously worked in an EU Regulatory Authority
• Previously worked in Manufacturing, QC, QA or Regulatory Compliance
• Project management
• Able to manage staff and teams
• Able to work with personnel of all levels within the organisation and with Third party companies
• All round experience in regulatory procedures
• Relevant Degree or higher qualification.

How to apply for the Head of Regulatory Operations role:

1. Click the button below to raise an email form
2. Attach your CV file to the email
3. Add any covering letter / personal notes to the body of the email
4. Send your completed job application through to us for processing.

Alternatively, for a confidential discussion concerning the Head of Regulatory Operations opportunity you can telephone Mark Johnson on +44 (0)1707 228639. Please be sure to quote 10523 in all correspondence relating to this role.