Senior Specialist, Study Start Up – Regulatory Affairs
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Senior study start-up specialist leading regulatory readiness for Ergomed’s rare disease and oncology clinical trials. Coordinating submissions, site agreements and activation across assigned countries.
Responsibilities:
- Lead and coordinate activities required to achieve site initiation readiness
- Deliver assigned study start-up and regulatory milestones within scope
- Make independent decisions regarding regulatory processes and documentation approaches
- Lead study start-up and regulatory activities for assigned countries or medium-complexity projects
- Prepare, review and quality-control regulatory and study start-up documentation, submissions, essential documents and translations
- Draft, negotiate, finalize and execute clinical site agreements, ancillary agreements and amendments
- Collaborate with legal, finance, clinical operations, sponsors, monitors and other functional teams
- Conduct site outreach and serve as point of contact for assigned sites
- Coordinate document processing leading to investigational product release and site activation readiness
- Review labels, patient information sheets, diary cards, insurance and related documentation for compliance
- Provide regulatory and study start-up strategic input
- Develop regulatory strategies, study start-up plans, joint operating procedures and core documents
- Identify and escalate project risks and support corrective/preventive actions
- Monitor project budgets and hours against budget, escalating out-of-scope work
- Provide expert advice to clients on complex regulatory queries and liaise with authorities
- Act as country or regional subject matter expert for regulatory and clinical study activity elements
- Maintain country intelligence repositories and disseminate regulatory changes
- Complete project trackers, correspondence logs, study portal/TMF filing and submission dossier quality control
- Support business development proposals, budgets and meetings
- Comply with SOPs, work instructions, training records and timesheet requirements
- Support junior staff with audits and inspections
- Contribute to SOPs, working practices and company initiatives
- Train, coach and mentor junior staff
- Perform other assigned duties
Requirements:
- Graduate degree in Chemistry or Life Sciences, Pharmacy, MD, or equivalent combination of education and experience
- Previous experience within the pharmaceutical/CRO industry
- Good knowledge of ICH GCP and national regulations for territories of competency
- Proficiency in English, both written and verbal
- Good written and verbal communication skills
- Excellent planning and organizational skills
- Strong planning, strategizing, managing, monitoring, scheduling, problem-solving and critiquing skills
- Ability to manage multiple tasks, set priorities, and adapt to changing work assignments
- Ability to exercise sound judgment and make decisions independently
- Remarkable attention to detail
- Excellent self-motivation and motivation skills
Benefits:
- Work-life balance
- Collaborative, international team environment
- Career growth opportunities
- Trusted to take ownership early
- Passionate and collaborative team of experts
- Training, coaching and mentoring opportunities
Similar Jobs
Team Lead – Customer Compliance
Team Lead overseeing KYC, verification, and screening for eCarsTrade, a European B2B used-car auction platform. Improving compliance processes, coaching the team, and advancing automation.
Compliance Officer, Payments
Compliance Officer building an independent compliance function for Binance’s licensed Kazakhstan payments business. Managing AML, sanctions, regulatory reporting, and financial crime risks.
Corporate Compliance – BSA SAR Investigator I
BSA SAR Investigator reviewing suspicious activity, filing SARs, and supporting AML compliance. Protecting Golden 1 Credit Union members through detailed financial investigations.
Senior Director, Compliance Monitoring & Surveillance
Senior compliance leader overseeing risk-based monitoring and surveillance for Empower’s financial services businesses. Directing regulatory controls, analytics, reporting, remediation, and compliance teams.
Senior Specialist – Regulatory Science
Senior Regulatory Science Specialist supporting US pharmaceutical and biologic submissions, labeling, and lifecycle management at Cencora. Coordinating compliant regulatory activities for clients and cross-functional teams.
Principal Regulatory Advisor – Non-Food
Principal Regulatory Advisor leading non-food consumer product compliance for SGS, a global testing, inspection and certification company. Advising clients on UK, EU and Irish legislation, packaging and regulatory risk.
Senior Lead, Insurance Compliance & Regulatory
Insurance compliance lead overseeing regulatory complaints, carrier audits, and escalation operations. Jerry’s AI-powered car-insurance app serves over 5 million customers.
Compliance Monitoring Specialist – Neurology
Remote compliance specialist monitoring Johns Hopkins neurology clinical-trial data. Reviewing records, supporting audits, tracking findings, and improving research compliance.
Compliance Director
Compliance Director guiding regulatory compliance for Gainbridge’s direct-to-consumer annuity platform. Partnering across product, marketing, technology, and operations within Group 1001.
Compliance Analyst
Compliance Analyst supporting Fanatics Markets’ event contracts and futures compliance infrastructure. Monitoring CFTC/NFA rules, surveillance, marketing reviews, AML/KYC, and regulatory inquiries.
Mortgage Compliance Officer
Remote Mortgage Compliance Officer reviewing Australian mortgage files for compliance and quality. Supporting brokers and improving lending processes for Wingman Group.
Senior Data Protection Analyst
Senior Data Protection Analyst analyzing Cyberhaven’s DDR platform to detect insider threats and investigate endpoint incidents. Supporting customers’ evolving data security strategies.
Regulatory and Site Start-Up Specialist
Regulatory and Site Start-Up Specialist supporting clinical trial submissions, site activation, and essential documents. Precision for Medicine integrates clinical operations, scientific expertise, laboratories, and data sciences.
Regulatory and Site Start-Up Specialist
Regulatory specialist supporting clinical trial submissions and site activation for Precision for Medicine, a life sciences CRO. Managing essential documents, ethics approvals, contracts, and country-specific regulatory requirements.
Government Compliance Manager
Government compliance manager supporting RTX’s aerospace and defense compliance program. Researching federal procurement rules, maintaining guidance, and assisting cross-functional contract compliance initiatives.
Corporate Compliance Manager
Corporate Compliance Manager overseeing AKI’s corporate, regulatory, and federal contracting compliance. Advising the CEO, coordinating audits, and driving CMMI process improvement across subsidiaries.
Policy and Regulatory Affairs Manager
Policy and Regulatory Affairs Manager advancing utility regulation and demand flexibility for EnergyHub, which turns smart devices into virtual power plants. Shaping U.S. policy, advocacy, and grid modernization strategy.
Food Regulatory Specialist I
Food Regulatory Specialist inspecting food facilities and enforcing labeling and sanitation regulations for North Carolina Agriculture. Home-based field role covering five North Carolina counties.
Deliverability & Compliance Manager – Cross-channel, SMS focus
Deliverability and Compliance Manager protecting Omnisend’s ecommerce messaging channels. Managing SMS operations, registrations, carrier compliance, investigations, and cross-channel deliverability improvements.
Global Security Governance, Risk & Compliance Manager
Global Security GRC Manager leading CMMC, vendor risk, data protection, and resilience programs. Driving security governance across engineering, manufacturing, and corporate environments.