Ssu & Regulatory Specialist with Experience in
hace 5 meses
**Description**
**SSU & Regulatory Specialist with experience in clinical trials focus logistics-Client Based Mexico-CDMX**
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**
**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 our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
**Job responsibilities**
- General - Responsible for providing quality on deliverables at the country level and follows 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 clear rationale for delays, assists with contingency plan to mitigate 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, keeps 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 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 overight from the SSU Country Manager.
- Local Site ID and Feasibility Support - Provides support with 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 country template contract and budget. Assists in producing site-specific contracts from country template. Under supervision assist in negotiations of budget and contract with 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.
**Qualifications**
**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 func
-
Ssu & Regulatory Specialist with Experience in
hace 5 meses
Tlahuac, México Syneos - Clinical and Corporate - Prod A tiempo completo**Description** **SSU & Regulatory Specialist with experience in clinical trials-Client Based Mexico-CDMX** 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...
-
Regulatory Affairs Specialist
hace 5 meses
Tlahuac, México Bayer A tiempo completo**Regulatory Affairs Specialist** **Position purpose** Act as LRA (Local RA) for all the daily activities that will ensure registrations of Radiology Medical Devices are properly done in LATAM region by submitting local dossiers, keeping country requirement table and SharePoint site folder structure updated, and ensuring the proper trackers are up to...
-
Regulatory Affairs Jr Specialist
hace 5 meses
Tlahuac, México Johnson & Johnson A tiempo completoDescription Kenvue is currently recruiting for: **Regulatory Affairs Jr Specialist** This position reports to Latam CMC Regulatory Affairs Manager and is based at Mexico City. **Who we are** At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands -...
-
Regulatory Affairs Specialist
hace 5 meses
Tlahuac, México Abbott Laboratories A tiempo completo**Regulatory Affairs Specialist** **Mexico City** **About Abbott** Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. **Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for...
-
In-business Regulatory
hace 5 meses
Tlahuac, México Citi A tiempo completo**Responsibilities**: - Responsible for leading the internal business control teams; working with leaders and business/functional leaders to ensure control policies and practices provide continuing value to the organization and ensure compliance with all applicable regulatory & policy requirements. - Accountable for audit and exam management, issue...
-
Regulatory Engagement Lead
hace 5 meses
Tlahuac, México Citi A tiempo completo**Responsibilities**: - Responsible for providing risk strategic analytics, information management across Citibank products and reports to senior management. - Responsible for communicating to executive management implications of existing and opposed regulation and developing potential responses. This may include regulations related to specific product or...
-
Regulatory Affairs Specialist, Export Countries
hace 5 meses
Tlahuac, México Solventum A tiempo completo**Job Description**: Regulatory Affairs Specialist, Export Countries (Solventum) Mexico City 3M Health Care is now Solventum At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the...
-
Mgr, Regulatory Intelligence
hace 7 meses
Tlahuac, México Syneos - Clinical and Corporate - Prod A tiempo completo**Description** **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...
-
Regulatory Specialist 2, Fsp
hace 5 meses
Tlahuac, México Novasyte A tiempo completoJob Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions - Under general supervision, serve...
-
Regulatory Solutions Officer
hace 5 meses
Tlahuac, México Nubank A tiempo completo**About Nubank** Nubank was founded in 2013 to free people from a bureaucratic, slow and inefficient financial system. Since then, through innovative technology and outstanding customer service, the company has been redefining people's relationships with money across Latin America. With operations in Brazil, Mexico, and Colombia, Nubank is today one of the...
-
Regulatory Sciences Manager
hace 5 meses
Tlahuac, México Pfizer A tiempo completoJOB SUMMARY Summarize the primary purpose & key accountabilities of the job. - Provide managerial oversight to the Regulatory Organization to execute regulatory strategies. - Support the Head of Regulatory Sciences Mexico to achieve the regulatory authorizations in the Country, within the legal standards and established timelines. - Coordination and...
-
Regulatory Advisor
hace 5 meses
Tlahuac, México Citi A tiempo completo**Responsibilities**: - Ensure accurate and timely delivery of key changes to the business by leading Global Change Management (GCM) process - Creating and managing end to end calendar with critical steps, dependencies and dates - Hosting kick-off calls with change owner to gather stakeholders, begin impact assessment and identify leads from each functional...
-
Regulatory Affairs Specialist
hace 5 meses
Tlahuac, México Edwards Lifesciences A tiempo completoMake a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail...
-
Start-up & Regulatory Specialist
hace 5 meses
Tlahuac, México Fortrea A tiempo completoAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Regulatory Senior Associate Chemistry
hace 5 meses
Tlahuac, México Pfizer A tiempo completoWhy Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...
-
Regulatory Advisor
hace 5 meses
Tlahuac, México Citi A tiempo completo**Responsibilities**: - Participates from inception through implementation, in cross-functional or cross business issues designed to ensure business compliance with laws, regulations, and policy requirements across key/complex risk levels. - Utilizes Issue Management processes and project management methodology from the initiation, planning, control...
-
Flavors Regulatory Manager
hace 5 meses
Tlahuac, México McCormick & Company A tiempo completoMcCormick & Company, Inc., a global leader in the spice, flavor, and seasonings industry, is seeking a full-time Flavors Regulatory Manager. This new hire will work at the McPesa, located in Mexico City. The Flavors Regulatory Manager will report to a Quality and Regulatory Director. McCormick & Company, Incorporated is a global leader in flavor. With over...
-
Pv Ra Mw Coordinator/ Experience in Safety Admin
hace 5 meses
Tlahuac, México Thermo Fisher Scientific A tiempo completo**Work Schedule** Other **Environmental Conditions** Office PV RA MW Coordinator - Provides support and coordination of review of safety and regulatory publishing documents on receipt. - Assists in reviewing document quality when tracking safety and regulatory publishing data in internal systems and uploading in internal and/or external electronic trial...
-
Flavors Regulatory Manager
hace 5 meses
Tlahuac, México McCormick & Company A tiempo completoMcCormick & Company, Inc., a global leader in the spice, flavor, and seasonings industry, is seeking a full-time **Flavors Regulatory Manager**. This new hire will work at the **McPesa**, located in **Mexico City**. The **Flavors Regulatory Manager **will report to a** Quality and Regulatory Director.** McCormick & Company, Incorporated is a global leader...
-
Regulatory Affairs Associate Consultant
hace 5 meses
Tlahuac, México ClinChoice A tiempo completoAre you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds. ClinChoice is searching for a **Regulatory Affairs Associate Consultant** to join one of our clients. **Main Job Tasks and Responsibilities**: -...