Senior Consultant Regulatory Intelligence (Portugal or Serbia based)
Updated:
January 7, ****
Location:
Dublin, CW, Ireland
Job ID:
********-OTHLOC-******DR
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything we do.
We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Discover what our 29,000 employees across 110 countries already know: work here matters everywhere.
Job Responsibilities
Gather new regulatory information through routine surveillance of agreed regulatory sources.
Reviews surveillance alerts and queries and determines actions to be taken.
Support ad-hoc research requests from the business and gather regulatory information for potentially new topics.
Manage Regulatory Intelligence Network list of functional SMEs.
Interacts with external and internal experts to collect country and region-specific regulatory intelligence.
Conducts searches within commercial Regulatory Intelligence databases to identify regulations and guidelines relevant for clinical regulatory intelligence.
Keeps abreast of regulations, trends, developments, and advances in the global regulatory environment.
Identifies and responds appropriately to issues and problems, providing innovative and effective solutions.
Recommends and implements enhancements of Syneos Health Regulatory Intelligence processes to maintain the Regulatory Intelligence System.
Performs other work-related duties as assigned.
The Regulatory Intelligence Department at Syneos Health impacts decision-making at the highest levels.
The team translates and refines Syneos Health regulatory intelligence from internal and external sources and combines knowledge from therapy areas and functions to deliver proactive advice outlining risks and new opportunities to the regulatory strategy and operations.
The Senior Consultant, Regulatory Intelligence is an internal facing role that supports keeping the Syneos Health Regulatory Intelligence System current and accurate via regular surveillance and interaction with subject matter experts.
Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive.
The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.
The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.
Further, nothing contained herein should be construed to create an employment contract.
Occasionally, required skills/experiences for jobs are expressed in brief terms.
Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
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