Global Provider of Expert, High-Quality Services to the Biopharmaceutical Industry. Your Full-Service Solutions Partner.
Senior Specialist, Regulatory Registration and Compliance
Location
Croatia
Posted
4 days ago
Salary
0
Seniority
Senior
Job Description
Senior Specialist, Regulatory Registration and Compliance
ERGOMED
• Prepare and manage marketing authorization (MA) submissions, including the preparation of local administrative documents, quality control (QC), and compilation. • Provide ad hoc regulatory advice on submission packages in the post-authorization stage of the medicinal product lifecycle. • Review and provide linguistic input for local Product Information and Mock-ups. • Serve as the primary contact point for regulatory affairs (RA) matters with national competent authorities (NCAs) and/or clients. • Involvement in project management of the network of local contact persons for Regulatory affairs. • Collect, process, and manage regulatory intelligence to keep the organization informed of key updates and changes. • Propose marketing authorization strategies tailored to client needs. • Act as a deputy for the line manager when required, ensuring seamless continuity in leadership and operations.
Job Requirements
- University education in Natural Sciences, Chemistry, Medicine, Pharmacy or Pharmacology
- Previous industry experience is essential
- Knowledge of Regulatory area and applicable legal and other requirements (both local and global) within pharmaceutical industry
- Excellent organizational skills with the ability to manage multiple projects and deadlines.
- A collaborative mindset, coupled with excellent communication skills to liaise with clients and regulatory bodies effectively.
- Advanced knowledge of English (both written and verbal)
- Experience with centralised procedures advantageous
- Experience with regulatory databases and dossier management software advantageous
Benefits
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language
Related Guides
Related Categories
Related Job Pages
More Compliance Jobs
Manager, Investigations, Ethics & Compliance
Mattel, Inc.We empower the next generation to explore the wonder of childhood and reach their full potential.
• Lead and conduct compliance and workplace investigations across the United States • Gather and analyze evidence, conduct interviews, assess credibility, and make objective findings based on facts and applicable policies • Prepare clear, concise, and fact-based investigation documentation, including interview notes, case summaries, findings, and recommendations • Manage investigations in a timely manner while maintaining consistency, objectivity, confidentiality, and adherence to Compliance and investigative best practices • Present investigation findings, risk assessments, and recommendations to Employment Law, People & Culture, and business leaders • Serve as a trusted advisor to People & Culture Business Partners and business leaders on complex workplace matters • Partner with Compliance colleagues to identify opportunities to enhance investigative processes, controls, policies, training, and risk mitigation efforts
• Support all aspects of the Grievance and Appeals (G&A) compliance program for Medicare, and Medicaid lines of business • Assume the primary role of interfacing with the Compliance department, Auditors, Vendors and G&A staff for purposes of monitoring and ensuring compliant operations • Interface with the Compliance Department and Fraud, Waste and Abuse teams to evaluate and address fraudulent activities impacting the G&A Department • Conduct internal audits, support external audits, develop policies and procedures, and ensure departmental compliance • In partnership with Compliance staff and G&A leadership, develop auditing and monitoring plans to assess compliance with all State, Federal and internal business rules and regulations • Serve as an inter-departmental liaison for compliance and FWA activities • Inform all business operations and workflow decisions to ensure that programs are compliant with State, Federal an internal business rules and regulations • Be fully informed and ensure compliant processes are in place on all G&A business operations • Maintain a current working knowledge of all applicable Medicare, and Medicaid rules and regulations • Conduct frequent monitoring activities of all G&A business operations, publish results and report out to G&A Leadership, Compliance Department, quality committees and other PacificSource leadership teams as applicable • Respond to all compliance related inquiries from internal Compliance Department Staff and external Auditors in a timely, professional and accurate manner
• Support all aspects of the Grievance and Appeals (G&A) compliance program for Medicare and Medicaid lines of business • Assume the primary role of interfacing with the Compliance department, Auditors, Vendors and G&A staff for purposes of monitoring and ensuring compliant operations • Interface with the Compliance Department and Fraud, Waste and Abuse teams to evaluate and address fraudulent activities impacting the G&A Department • Conduct internal audits, support external audits, develop policies and procedures, and ensure departmental compliance • Develop auditing and monitoring plans to assess compliance with all State, Federal and internal business rules and regulations • Serve as an inter-departmental liaison for compliance and FWA activities • Inform all business operations and workflow decisions to ensure that programs are compliant with State, Federal and internal business rules and regulations • Be fully informed and ensure compliant processes are in place on all G&A business operations • Conduct frequent monitoring activities of all G&A business operations, publish results and report out to G&A Leadership, Compliance Department, quality committees and other PacificSource leadership teams as applicable • Respond to all compliance related inquiries from internal Compliance Department Staff and external Auditors
Controlling Profesional
SiemensSiemens Energy, part of Siemens, aims to be a global leader in the energy technology field, whose mission is to reduce the environmental impacts of the energy f
Title: Professional Controlling Location: Hybrid (Remote/Office) Mexico (Any Siemens location in Mexico) Job Type: Full-time Job Description We are Siemens. A team of over 5,000 phenomenal minds who are shaping the future and you can be a part of it! We have factories all over Mexico, full of hardworking people who help us defy today and work toward a brighter tomorrow. If we all thought the same thing, we would never think of anything new! That's why we recruit great minds from all walks of life. Responsibilities - Monitoring and analysis of results of operational areas (PMs/CPMs, C&C, ENG PA, ENG MV, CC) - Update, monitoring and analysis of the monthly P&L Sales (BI and Excel) - Preparation of annual planning and updating of quotas (C&C, ENG PA, ENG MV, CC) - Productivity control assigned operational areas - Reporting and recording of HORING transfer of costs to Orders in Development - Cost-center controlling internal cost reporting and transfers, JETS elaboration - Control of services other countries (PATAC), personal collections USA - Internal development orders and models - Charges for Services with OC or Referral with SLA (Non Revenue Order) - CAM when there is horing of C&C, CC, ENG PA Requirements - Minimum 3 years of experience in controlling for Field Service areas or teams - Fluent English - Good command of Excel and Power BI - Experience in handling data - Experience with Labor Hour Service Reporting - Experience with Service Quota Calculation Equal Employment Opportunity Statement Siemens is an equal opportunity and affirmative action employer that encourages diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal law, state or local law.


