Regulatory Affairs Specialist I (Mumbai Local candidate only)
Site Start-Up & Regulatory Specialist I
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
- General – Responsible for providing quality on deliverables at the country level and following project requirements and applicable country rules, with oversight from the SSU Country Manager.
- Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real-time; if forecasted timelines are not reached provides a clear rationale for delays, assists with a contingency plan to mitigate the impact, and escalates the issue as soon as identified.
- Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
- Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keep training records updated accordingly, and ensures timesheet compliance.
- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
Responsible for one or more of the following functions at the country level:
- Local Submissions Specialist – Follows the project direction provided by the designated country start-up advisor (CSA) and SSUL. May serve as a point of contact for the SSUL/PM (or designee) during start-up on allocated projects. Compiles and/or reviews essential document packages for site activation and may also be involved in essential document collection from the site.
- Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required and under supervision. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules, with oversight from the SSU Country Manager.
- Local Site ID and Feasibility Support – Provides support with the site selection lead and PM/SSUL to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
- Local Investigator Contract and Budget Negotiator – Supports the SSUL to agree on the country template contract and budget. Assists in producing site-specific contracts from the country template. Under supervision assist in negotiations of budget and contract with the site and via Site Contracts Service Centre and SSUL lead with Sponsor until resolution of issues and contract execution. Assists with quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
What we’re looking for
- Associate’s Degree or equivalent combination of education and training.
- Good understanding of clinical trial process across Phases II-IV and ICH GCP, Ability to interact effectively and appropriately with investigative site personnel.
- Good organizational skills and good attention to detail, with proven ability to handle multiple tasks effectively.
- Ability to take direction from multiple individuals and set priorities accordingly.
- Ability to effectively communicate across multiple function groups (clinical team, PM, Director).
- Demonstrated ability to work independently, as well as part of a team. Utilize problem-solving techniques effectively.
- Quality-driven in all managed activities.
- Flexibility and willingness to adapt to rapidly changing environments and learn/perform new functions.
- Strong computer skills, including Word, Excel, PowerPoint, and Publisher.
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.
- 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. E-quivalent experience, skills, and/or education will also be considered so the qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes 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, about 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.