Assoc Dir, Regulatory Intelligence

Description

Associate Director, Regulatory Intelligence

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 that 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.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know: **

WORK HERE MATTERS EVERYWHERE**

Job Summary

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 Associate Director, Regulatory Intelligence is a key internal and external facing role that leads and shapes strategic discussions, investment decisions and supports operational execution of the Regulatory Intelligence Department strategy. **

Job Responsibilities**

• Partner with the Departmental Leadership to create and deliver a robust global Regulatory Intelligence departmental strategy and plan for Syneos Health.
• Ensure that clinical regulatory intelligence is collected and maintained in Syneos Health Regulatory Intelligence System (RIS)
• Proactively evaluate and identify systems, automation, tools, and processes for tracking and reporting of Regulatory Intelligence
• Work closely with Country Subject Matter Experts (SMEs) from all/each region contributing to the overall understanding of the local regulatory landscape.
• Promote and ensure understanding with key stakeholder of the organization wide regulatory intelligence system, department purpose, deliverables and points of contact.
• Horizon scan, critically review and translate current and upcoming regulatory changes into clear internal strategic statement.
• Proactively engage and communicate with senior leadership representing the Regulatory Intelligence Department acting as a resource for technical knowledge and guidance making recommendations to support efficient and effective outcomes.
• Support the solutioning of escalations and proactively engage with internal stakeholders to remedy and reduce risk.
• Keep abreast of current data, trends, regulatory knowledge, developments and advances in the global regulatory environment.
• Support impact assessments of regulatory documents and guidelines on Syneos Health procedures as applicable and as assigned by management.
• Advise, consult and make final recommendations to all aspects of clinical regulatory intelligence.
• Identify and respond appropriately to issues and problems, providing innovative and effective solutions.
• Recommend and implement enhancements of Syneos Health Regulatory Intelligence processes to maintain the Regulatory Intelligence System
• Assume functional manager role for managers and staff in the Regulatory Intelligence department:
• Define, lead and oversee team operational plans.
• Ensure staff members fulfill their responsibilities in accordance with Regulatory Intelligence controlled documents and other relevant procedures.
• Communicates team / individual goals and expectations to ensure direct reports understand their responsibilities.
• Ensure performance and development processes and conversations are undertaken effectively.
• Monitor team resource capacity keeping FM informed about relevant trends or changes.
• Performs other work-related duties as assigned.
• Minimal travel may be required (up to 25%)

Qualifications

QUALIFICATION REQUIREMENTS

• BA/BSc in related disciplines or regional equivalent or equivalent combination of education and experience.
• 8-10 years of industry experience within Regulatory Intelligence or Regulatory Affairs/Operations functions.
• Comprehensive regulatory knowledge and understanding of pharmaceutical and or medical device product development.
• Ability to be flexible, adapt to change, work independently, as well as part of a team in a matrix environment.
• Ability to think strategically, make effective decisions based on data and insights and manage multiple priorities while delivering high quality work in a dynamic environment.
• Fluency in speaking, writing, and reading English.
• Excellent communication and interpersonal skills.
• Excellent problem solving and decision-making skills.
• Demonstrable leadership and people management skills.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

_“Syneos Health is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Syneos Health is willing to provide reasonable accommodations required for a medical condition or disability.”

_ 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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