Regulatory Submissions Manager
Location
Kazakhstan
Posted
121 days ago
Salary
0
Seniority
Senior
Job Description
Regulatory Submissions Manager
ICON plc
• Lead regulatory activities and submissions independently, with prior experience in areas such as CTA/IND/MAA • Provide regulatory guidance and efforts to internal teams • Participate in agency interactions and regulatory submissions • Contribute to developing best practices within ICON Regulatory Affairs through your insight of regulatory processes and guidelines • Work collaboratively as part of a regulatory or cross-functional team, depending on project size and nature
Job Requirements
- Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred
- Minimum of 6 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry
- Prior experience with various regulatory submissions, including CTA/IND/MAA
- Ability to lead internal teams and carry out regulatory activities independently
- Strong understanding of global regulatory requirements and guidelines
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Related Guides
Related Categories
Related Job Pages
More Compliance Jobs
• Develops and implements company-wide environmental protection and compliance programs and policies. • Builds Environmental Management Systems which focuses on preventing, correcting, and ultimately reducing potential environmental, regulatory and community impacts associated with our operational activities. • Develops key performance indicators to understand leading indicators of performance. • Partners with field environmental protection leads and specialists to understand risks and build programs centered around these risks. • Partners with Compliance Audit Services to understand issues identified in audits and ensure issues are corrected on a timely basis. • Designs and implements strategic project plans in response to more complex compliance and liability issues and problems. • Monitors emerging issues in environmental regulatory requirements. Initiate and participate in developing the company’s response to new or changing regulations on a regional basis.
• Gather new regulatory information through routine surveillance of agreed regulatory sources • Reviews surveillance alerts and queries and determines actions to be taken • Support ad-hoc research requests from the business and gather regulatory information for potentially new topics • Manage Regulatory Intelligence Network list of functional SMEs • Interacts with external and internal experts to collect country and region-specific regulatory intelligence • Conducts searches within commercial Regulatory Intelligence databases to identify regulations and guidelines relevant for clinical regulatory intelligence • Keeps abreast of regulations, trends, developments, and advances in the global regulatory environment • Identifies and responds appropriately to issues and problems, providing innovative and effective solutions • Recommends and implements enhancements of Syneos Health Regulatory Intelligence processes to maintain the Regulatory Intelligence System
Compliance & Administration Manager
Avantpage TranslationsTranslation services with empathy beyond words
• Review and interpret client contracts, amendments, and compliance documentation. • Identify contractual and regulatory risks and recommend mitigation strategies. • Lead client audit coordination (5–6 per year on average). • Maintain ISO audit readiness (ISO 9001 and/or ISO 17100 preferred). • Support SOC 2 alignment in collaboration with internal teams. • Ensure certifications remain current and compliant. • Partner with Business Development to prevent blind contract execution. • Oversee compliance-related registrations, renewals, and certifications. • Manage structured documentation and reporting. • Support administrative decision-making processes. • Ensure organized and accessible compliance records.
Licensing & Permitting Regulatory Compliance Specialist
Destination Pet, LLCPet care is a lifelong journey. Welcome to your destination.
• Manage all new applications, renewals, amendments, transfers, and closures with local, county, state, and federal agencies. • Conduct jurisdictional research to identify the necessary licenses and permits for each center type. • Maintain centralized tracking of all regulatory obligations, ensuring clear visibility of deadlines. • Ensure all filings and submissions are completed 100% on time. • Retain and organize applications, approvals, and correspondence in approved systems to maintain audit readiness. • Maintain regulatory records in accordance with the Company’s Record Retention & Destruction Policy. • Monitor statutory and regulatory changes affecting pet care and veterinary operations. • Keep a regulatory change log and assess the impact across the portfolio. • Identify compliance gaps, risks of lapses, and potential agency enforcement exposure. • Promptly escalate material risks, Notices of Violation, or enforcement concerns to Legal and Compliance leadership. • Classify licensing obligations by risk tier to prioritize high-impact requirements. • Track inspection schedules, outcomes, citations, and corrective action deadlines. • Maintain a centralized repository of inspection reports and agency correspondence. • Coordinate with Operations, Safety, and Facilities to ensure timely completion of corrective actions. • Manage incoming field support tickets related to licensing and regulatory compliance. • Communicate clearly, professionally, and decisively with operational stakeholders. • Exhibit exceptional organizational discipline and control over deadlines.



