Senior Specialist/Manager, Regulatory Intelligence and Analytics
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Job Description
Senior Specialist/Manager leading regulatory intelligence projects at PrimeVigilance. Managing project deliverables and regulatory strategy with a focus on pharmaceutical regulation.
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
- Provide regulatory strategic input to internal and external customers and promptly identify and address any risk/potential risk
- 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
- Monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS
- Provide support to proposal development and input to budgets, provide department representation to BD meetings as required
- 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
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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