Job Closed
This listing is no longer active.
Fortrea is a contract research organization (CRO) that provides advanced laboratory-focused services that help change lives. On a mission to deliver “life-cha
Regulatory Submissions Manager II
Location
Italy
Posted
124 days ago
Salary
0
Seniority
Senior
Job Description
Regulatory Submissions Manager II
Fortrea
• Collaborate with peers across the organization to achieve client-centric delivery in a matrix organization • Oversight and accountability for RA IRB/EC and Third Body submissions • Coordinate responses to queries and ensure required time lines are met • Provide consolidated country requirements and regular status updates to project team and Client • Ensure compliance of deliverables to applicable regulations and guidance requirements • Provide highest quality advice on regulatory issues to project teams and clients • Evaluate impact of clinical/regulatory changes on assigned projects • Liaise with local teams and support with RA, IRB/EC, and Third Bodies • Manage applicable user access and back up in case of unexpected absences • Proactively engage in quality assurance and risk management activities • Support audits and inspections as needed • Contribute to group development through process improvement initiatives • Mentor junior Site Readiness team members
Job Requirements
- Recommended: Bachelor's Degree in Life Sciences or equivalent
- Minimum 3 years of experience in the Pharmaceutical/CRO industry in Regulatory Affairs or Drug Development
- Strong CTIS experience needed.
Benefits
- Professional development opportunities
Related Guides
Related Categories
Related Job Pages
More Compliance Jobs
Role Description As a Deputy Head of Compliance, you’ll assist the Head of Compliance to ensure all of Deblock’s products meet regulatory requirements and the annual permanent control plan is executed. You’ll be part of the Compliance team for our regulated entity and will help design, lead and shape the future of oversight and compliance. Your speed, ability to deliver, and capacity to come up with the most elegant solutions that are compliant and offer the best customer experience will make you one of the pillars of our team. We want to revolutionise the FinTech industry. Create a new paradigm. And we need the best minds to do it 🧠 🚀 - Defining, developing, managing, refining and documenting the Permanent Control Plan to manage all sources of regulatory risk and provide reporting which meets the needs of the regulator, local and Group management - Supporting the business where necessary regarding the launch of products to ensure regulatory requirements are met, as appropriate - Determining identification and verification standards for customer take-on and AML compliance - Overseeing licence maintenance and new licence applications - Communicating with all necessary staff to ensure they understand their responsibilities and are trained in Deblock policies and procedures to identify financial crime, escalate suspicious activity by making internal reports and make external reports to the regulators and other law enforcement bodies in a timely manner Qualifications - Deep knowledge of the EU regulatory environment and key financial crime regimes - Experience in overseeing and executing a permanent control plan - Ability to exercise oversight, knowledge and understanding of financial crime and AML policies, procedures and control arrangements in a complex financial operation Requirements - Experience leading control function - Experience working in a crypto company - Professional qualification from an internationally recognised body (e.g. ICA, ACAMS) Benefits - Competitive salary and a stock options sign-on bonus - The best tech for your job - 25 days of paid holidays + RTT - Option to work 100% remotely - Ability to work abroad for 4 months a year
Compliance Manager, Quality Oversight Lead
Thermo Fisher ScientificThe World Leader In Serving Science
• Be a dedicated, single point of Quality contact for client Partners with Ops to establish a consistent Quality culture across the studies or portfolio • Attend regular partnership level and ad hoc team meetings • Provide direction and recommendation for issue avoidance • Continuous awareness and periodic review of QE/SSM/SB/sPIP/Audit/Inspections • Escalate appropriately to Client Quality/Quality Partner/DevOps/bPL/PDL to minimize client impact and improve outcomes
• Leading the development, implementation, and maintenance of an anti money laundering program within Lux Vending, LLC’s institution. • Ensuring compliance with current AML regulations, and other relevant legislation (e.g the USA Patriot Act). • Developing and maintaining a risk assessment framework for products and services, clients and customers, and other issues relating to money laundering. • Keeping and maintaining records of high risk customers, and reporting suspicious activities to the authorities. • Arranging and implementing inspections and audits from third-party organizations, and making compliance recommendations based on their findings. • Briefing and reporting to senior management on matters relating to internal AML compliance policies and procedures. • Overseeing and implementing an ongoing AML training program for other employees namely initial training and ongoing training. • Complete annual independent review. • Enhance compliance program with usage of appropriate AML software available as it relates to the needs of Lux Vending, LLC. • State Licensing – Ensure that Lux Vending is licensed in the various states it operates in the event that is requires a license • Case Management – Manage all investigations ensuring they are readily complete in a timely fashion and that the end result is the best result. • Law Enforcement- Cooperating with law enforcement with reasonable requests for general information and information on customers. In addition, the • AML Compliance officer will form relationships with law enforcement to collaborate on how to improve communication and our AML program. Lux • Vending`s participation in blockchain alliance will serve as a key resource for this. • Banks- The AML Compliance Officer will respond to all bank related compliance requests as necessary. In addition, the AML Compliance Officer will assist Lux Vending in expanding its banking relationships as needed. • Cryptocurrency Exchanges- The AML Compliance office will take the lead in applying to additional cryptocurrency exchanges as necessary. • Other Policies: The AML Compliance Officer will be responsible for maintaining and updating Lux Vending`s Disaster Recovery Policy, Cybersecurity • Policy, and Customer Disclosures and Agreements as necessary.
Compliance Manager
Omilia - Conversational IntelligenceOmilia is the leading provider of Natural Language Understanding enabled IVR & natural dialogue interaction solutions.
The Mission: We are looking for a Compliance Manager who acts as a strategic partner to the business. You will sit at the intersection of Operations, Security, and Law. You are not here to tick boxes. You are here to build a resilient, "audit-ready" organization that can adapt to any future standard without slowing down. Requirements Benefits Fixed compensation; Long-term employment with the working days vacation; Development in professional growth (courses, training, etc); Being part of successful cutting-edge technology products that are making a global impact in the service industry; Proficient and fun-to-work-with colleagues; Apple gear Omilia is proud to be an equal opportunity employer and is dedicated to fostering a diverse and inclusive workplace. We believe that embracing diversity in all its forms enriches our workplace and drives our collective success. We are committed to creating an environment where everyone feels welcomed, valued, and empowered to contribute their unique perspectives without regard to factors such as race, color, religion, gender, gender identity or expression, sexual orientation, national origin, heredity, disability, age, or veteran status, all eligible candidates will be given consideration for employment.




