Associate - Regulatory Intelligence and Analytics

13 hours ago

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Logo of ERGOMED

ERGOMED

Oncology • Neurology • Respiratory diseases • Orphan drugs • Metabolic diseases

1001 - 5000

Description

• Perform regular screening of regulatory legislative requirements updates and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes • Provide internal teams with 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 administrative support to BD activities • 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.

Requirements

• Degree in Chemistry or Life Sciences, Nursing or equivalent experience • Minimum previous work experience preferable but not required; No previous experience within the pharmaceutical/CRO industry necessary • 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 • Proficiency in English, both written and verbal • Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint

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