Sr Country Regulatory Specialist, Clinical Research - 100% Remote in Mexico, English advanced

Sr Country Regulatory Specialist, Clinical Research - 100% Remote in Mexico, English advanced

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
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 deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

Perform assigned activities related to country regulatory operations. Responsible for providing delivery and expertise in country ethics and regulatory submissions from startup until project end, ensuring that activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards. Serve as main country-level contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs) under the direction and supervision of the Project Lead (PL), Regulatory Lead (RL), or Site Activation Manager (SAM). Maintains regulatory country intelligence in regulatory intelligence systems. May directly interact with Customers regarding requirements from RA or other local regulatory entities. May consult on pre-award regulatory submission strategy. Accountable to the PL/RL/SAM at the project level for regulatory submission and country regulatory maintenance tasks, and line manager for other country specific deliverables.

Core Responsibilities

 

• Responsible for providing quality deliverables at the country and site level. Follows project requirements and applicable country rules, with oversight at the project level from the PL/RL/SAM.       
• Expert knowledge of RA/EC processes, requirements, and timelines. Maintain current knowledge of applicable regulations and guidelines. Identify relevant laws, regulations, and guidance documents covering pre-and/or post-market requirements.
• Provide country-level SME knowledge at the pre-award stage to support robust business development presentations based on the project-specific requirements and timelines of the project.
• Provide country-level SME knowledge during the site-selection process to support the selection of appropriate sites based on the project-specific requirements and timelines of the project.        
• Maintains Intelligence on country specific start up timelines. Provides strategic recommendations to project teams
• Forecast submission and approval timelines at the project level, track milestone progress in agreed tracking system, analyze delays, propose mitigation plans, and escalate risks appropriately. 
• prepare and submit Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authority or hospital approval submissions as required while ensuring compliance with local regulatory requirements. 
• As required by local regulations, prepare ongoing submissions to the applicable authorities for amendments, periodic notifications required by central and local EC and RA, safety notifications, and other local regulatory authorities as needed within the country.
• Directly interact with RAs and ECs, identifying solutions when issues arise. Coordinate, contribute to, and submit RA/EC query responses. When necessary, influence RA/ECs via local CRO associations.
• Serve as the country-level regulatory SME point of contact through the life of assigned projects.
• Ensure all relevant documents are submitted to the Trial Master File (TMF) in compliance with SOPs and Customer requirements. 
• Serve as country level regulatory SME maintaining country intelligence in regulatory intelligence systems, contributing and validating information as the scope of the regulatory intelligence system expands. Completes / contributes to Regulatory Impact Assessments and implements Operational Actions as regulations change.
• Develop or support the creation of local country regulation training materials.
• Support training and mentoring more junior Country Regulatory Specialists.
• When required, provide SME knowledge and support to the Syneos Health Procurement team in managing Ethics/IRB vendors.
• Ensure continuous improvement of quality in all components at the country level where assigned (submissions, communication to Competent Authorities and ECs, etc.). Provide input to SOPs and WIs.
• Review and comply with applicable Standard Operating Procedures (SOPs) and Work Instructions (WIs), ensure training compliance, and maintain accurate timesheet reporting.
• Monitor workload/scope, budgeted effort, and project hours; escalate discrepancies in a timely manner.

Qualifications

• Minimum of a BA or BS preferred     
• 5-6 years minimum experience working in a Clinical Research environment, or an equivalent combination of education and experience that provides the necessary knowledge, skills and abilities to perform this job.       
• Detailed understanding of clinical trial process across Phases I-IV and ICH GCP.     
• Detailed understanding of clinical trial submission processes per-country and local regulations.       
• Experience in working to applicable GxPs (e.g. GVP, GCP, ISO 14155) etc.
• Strong organizational and problem-solving skills, with a proven ability to meet deadlines with high quality.     
• Strong presentation, documentation, influencing, and communication skills (both written and spoken) as well as a team-oriented approach.
• Knowledge and interpersonal skills necessary to effectively train and mentor more junior Country Regulatory Specialists.    
• Proficient computer skills in Microsoft Office Suite, web-based systems, voicemail, Email and Internet are necessary.  
• Ability to manage competing priorities and work in a dynamic fast-paced environment.   
• Demonstrated ability to work independently as well as part of a team.

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.

http://www.syneoshealth.com

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.