Senior Specialist/Manager, Regulatory Intelligence and Analytics
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Job Description
Senior Specialist/Manager handling regulatory intelligence and analytics projects at PrimeVigilance. Leading compliance efforts and providing strategic regulatory input for pharmaceutical services.
Responsibilities:
- Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
- 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, 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 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.
- Provide feedback on performance of vendors to aid their assessment.
- Provide input to department / company initiatives and contribute to the design/review of SOPs/working practice/guidance.
- May also be required to line manager.
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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