Specialist, Regulatory Intelligence and Analytics

Perform quality control of regulatory intelligence screening of legislative requirements updates and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.

Provide internal teams and Clients with expertise and guidance on national requirements.

Ensure compliance with company procedures processes training records systems and any other tools

Promptly identify and escalate risk/potential risk to the project team which may jeopardise deliverables.

Maintain awareness of allocated tasks and hours and promptly identify and escalate any OoS.

Provide support to proposal development and input to budgets provide department representation to BD meetings as required.

Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.

Participate in preparation for audits/inspections and provide department representation for assigned projects as required.

Provide feedback on performance of vendors to aid their assessment.

Communicate suggestions for changes to departmental/company processes/procedures and contribute to department initiatives.

Qualifications :

Degree in Chemistry or Life Sciences Nursing or equivalent experience

Minimal previous experience within the pharmaceutical/CRO industry Good knowledge of ICH GCP and/or GVP and national regulations for territories of competency

Good planning and organizational skills

Good written and verbal communication skills to clearly and concisely present information

Strong interpersonal skills in a fast-paced deadline oriented and changing environment

Good attention to detail 

Excellent self-motivation skills

Basic understanding of ICH GCP across all areas

Additional Information :

What we offer

• Diverse tasks - data mining screenings analysis requirements review.
• Chance to build a broad and comprehensive knowledge on PhV processes and requirements
• Chance to expand knowledge on other areas covered by Regulatory and Clinical Delivery department i.e. clinical trials marketing authorisations XEVMPD PV Network
• A role in development of RI processes in a motivating environment

Remote Work :

Yes

Employment Type :

Full-time