Senior Regulatory Project Manager

Job Title:

Senior Regulatory Project Manager

Job Type:

Full-time

Country:

UK

Location:

Home-based

Job Summary:

The Senior Regulatory Project Manager will report to the Head of Regulatory in the following responsibilities for Diurnal Group companies (including Diurnal Europe B.V.):

Responsibilities: For Diurnal Group companies (including Diurnal Europe B.V.)

• Support the Head of Regulatory in devising and developing the Company's regulatory strategies for all development projects, manufacturing improvements, and the continued registration and licensing for all established products when applicable, including lifecycle management.
• Act as a point of contact for all regulatory interactions with relevant agencies, including, but not limited to, application for and maintenance of clinical trial/investigational new drug applications, preparing all pre- and post-meeting strategies, and responses and life cycle management.
• Support the Company at regulatory meetings with the Food and Drug Administration, European Medicines Agency, and other global regulatory agencies as required.
• Preparation of registration dossiers and submission of Marketing Authorisation Applications (MAAs) / New Drug Applications in line with regulatory authority requirements; and interaction with all licensing partners, and designated vendors such as Contract Research Organisations and others where applicable, to facilitate the submissions of MAAs in their territories.
• Support the Company in the preparation of all product information (including artwork), and provide advice and support in conjunction with the Head of Regulatory to ensure all manufacturer/importer and wholesale dealer licenses are maintained, as well as regulatory compliance with all change controls and Standard Operating Procedure (SOP) activities.
• Work closely with the Company's Head of Quality, Head of Clinical, and Product Development Director to ensure that clinical and manufacturing activities are conducted in accordance with Good Clinical Practice, Good Manufacturing Practice, and the associated local statutory requirements.
• Support the Head of Regulatory in the design and planning of the development programs, both for the Company's lead products (Chronocort® and lnfacort® / Alkindi®), and also for the Company's product pipeline, to ensure they meet appropriate regulatory requirements and standards.
• Attend and participate at certain Company meetings (such as development meetings as required), at locations to be mutually decided by the Company and the employee.
• Responsibilities apply across all GXPs for all Diurnal Group companies including Diurnal Europe B.V.
• Utilise and maintain and help Administer Regulatory Information Management Systems (Veeva Submissions Vault and Archive)
• Perform all business-related activities that may be reasonably requested and as instructed by the respective Company Director or Head of Department
• Complete all the above activities within the framework and in compliance with Diurnal SOPs and other documentation in force within the Company.

Requisite Skills, Experience and/or Qualifications
The Senior Regulatory Project Manager will require:
Essential:

• Education to a minimum of first-degree level or equivalent in biomedical sciences or other relevant discipline.
• At least 5-10 years’ experience in pharmaceutical regulatory affairs, including with both clinical trial and marketing authorisation applications.
• Experience working in both project teams and independently, and to timetables/deadlines
• Excellent communication skills, both oral and written.
• Experience with electronic Common Technical Document submissions including monitoring publishing activities
• Experience with both Centralised EU MAA and US FDA NDA and IND regulatory procedures.
Desirable
• Experience with EU, and US submissions portals
• Support for ROW submissions in Australia and Israel

APPLY ONLINE

You are applying for the following position:

Senior Regulatory Project Manager

Job Type:

Full-time

Country:

UK

Location:

Home-based

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