Mgr, Regulatory Intelligence

2 weeks ago

United Kingdom Syneos Health, Inc. Full time

The Regulatory Intelligence Department at Syneos Health impact decision-making at the highest levels. The team translate and refine Syneos Health regulatory intelligence from internal and external sources and combine knowledge from therapy areas and functions to deliver proactive advice outlining risks and new opportunities to the regulatory strategy and operations.
The Manager, Regulatory Intelligence is a key internal facing role that ensures the Syneos Health Regulatory Intelligence System is current and accurate via regular surveillance and interaction with subject matter experts.
Ensures that clinical regulatory intelligence is collected and maintained in Syneos Health Regulatory Intelligence System (RIS):
o Ensures that the country specific regulatory requirements are current and accurate and available for services offered by Syneos Health for countries in which the organization operates or intends to operate in.
o Ensures that regulatory intelligence data is available in a standardized format within the Regulatory Intelligence System so that it can be used for project work, client consultation etc.
o Interacts with external and internal experts to collect country and region-specific regulatory intelligence.
o Work closely with Country SMEs contributing to the overall understanding of the local regulatory landscape.
o Conducts searches within commercial Regulatory Intelligence databases to identify regulations and guidelines relevant for clinical regulatory intelligence.
o Understands applicable local, national, and regional regulations and translates them into organizational best practices.
o Documents the interpretation in a standardized format within the Regulatory Intelligence System in line with implemented procedures and business needs.
o Reviews surveillance alerts and queries and determine actions to be taken through to implementation.
· Advises, consults, and makes final recommendations to all aspects of clinical regulatory intelligence.
· Keeps abreast of regulations, trends, developments, and advances in the global regulatory environment.
· Supports impact assessments of regulatory documents and guidelines on Syneos Health procedures as applicable and as assigned by management.
· Recommends and implements enhancements of Syneos Health Regulatory Intelligence processes to maintain the Regulatory Intelligence System
· Provides regulatory and technical training within the department and/or other departments/stakeholders, as required.
· Timely and active participation and completion of all company and departmental requirements such as time reporting, meetings, performance reviews, etc.
· BS degree or equivalent demonstrated experience in a relevant field
· Clinical research experience required including significant regulatory intelligence experience or regulatory affairs or regulatory operations, preferably from a clinical research organization.
· Strong research skills required to support routine surveillance activities to detect, monitor, and synthesize complex regulatory information.
· Ability to react to internal and external changes, trends and development in the regulatory environment that may impact Syneos Health
· Knowledge of niche regulatory topics preferred.
· Fluency in speaking, writing, and reading English.
· Good people management, project management, problem-solving, and decision-making skills.
· Further, nothing contained here should be construed to create an employment contract. Any language held here is intended to fully follow all obligations imposed by the legislation of each country in which it works, 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.
Syneos Health has a voluntary COVID-19 vaccination policy. Additionally, certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees. These employees are required to submit proof of vaccination to Syneos Health and maintain compliance with these requirements.
We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

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