The Senior Associate, Regulatory Intelligence and Analytics is responsible for completing regulatory deliverables based on an established regulatory plan.
They also serve as a liaison between regulatory and other functional areas including external partners, clients, authorities, and/or consultants in the planning, organizing, and preparing of regulatory deliverables following project, corporate, and industry regulatory strategies.
Role and Responsibilities Provide intelligence on requirements and contribute to the development of the strategy and set up activities including Regulatory Management Plan, joint operating procedures, POAs, and core documents.
Support identification of issues.
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 jeopardize 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.
Qualifications Degree in Chemistry or Life Sciences, Nursing, or equivalent experience.
Previous regulatory experience within the pharmaceutical/CRO industry.
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.
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders, and ages can contribute and grow.
To succeed, we must work together with a human-first approach.
Why?
Because our people are our greatest strength leading to our continued success in improving the lives of those around us.
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