Senior Specialist/Manager, Regulatory Intelligence and Analytics
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Job Description
Senior Specialist/Manager in Regulatory Intelligence and Analytics at PrimeVigilance managing regulatory projects and ensuring compliance with industry standards.
Responsibilities:
- Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables
- Perform quality control of regulatory intelligence screening of legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes
- Provide regulatory strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures
- Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures
- Ensure compliance with company procedures, processes, training records, systems and any other tools
- Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated
- Provide training, coaching and mentoring to junior members of staff
- Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery
- Participate in and/or support junior members in preparation for audits/inspections and provide department representation for assigned projects as required.
Requirements:
- Degree in Chemistry or Life Sciences, Nursing or equivalent experience
- Strong previous experience within pharmaceutical or CRO industry or Regulatory body
- Previous Project Management experience is desirable
- Knowledge of Pharmacovigilance/Regulatory field
- Good knowledge of ICH GCP and/or GVP and national regulations for territories of competency.
- Fluent Proficiency in English, both written and verbal.
- Additional languages are desirable.
- Strong organization skills and detailed orientated approach to work
Benefits:
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language
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