Scientific Affairs Specialist - Germany

Karo Group, Inc.; Düsseldorf; Hybrid; EUR 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Hybrid work model

Global exposure

International team

Zusammenfassung

Karo Healthcare in Düsseldorf is seeking a Scientific Affairs Specialist to serve as the local regulatory and pharmacovigilance expert for Germany, ensuring GVP compliance, product quality, and patient safety across the portfolio.

You will collaborate with Global Scientific Affairs, PV, Quality and commercial teams, handle safety information, regulatory submissions, labelling, and provide guidance to healthcare professionals and authorities, contributing to lifecycle management and compliance.

Qualifikationen

• University degree in Medicine, Pharmacy, Veterinary medicine, Biology, Chemistry, or a comparable scientific discipline.
• 4+ years’ experience in Regulatory Affairs, Quality, or Scientific Affairs within healthcare.
• Experience with pharmacovigilance processes, safety case reporting, and GVP requirements.
• Solid understanding of product compliance, product lifecycle management, and health authority interactions.
• Experience reviewing marketing materials and promotional claims for compliance.
• Experience with local submissions and dossier handling.
• Experience with authority-facing pharmacovigilance communication.
• Experience delivering pharmacovigilance or compliance training.
• Comfortable working cross-functionally with affiliates, distributors, and local commercial teams in an international, fast-moving organization.
• Fluent in English and German.

Aufgaben

• Act as the local Scientific Affairs, Regulatory and Pharmacovigilance expert across Germany, providing expert guidance on local regulatory requirements, GVP compliance, product quality and patient safety across the Karo portfolio.
• Serve as a key link between Global Scientific Affairs, PV, Quality and local commercial teams, ensuring that local activities and product lifecycle management comply with applicable regulatory requirements and global standards.
• Be a key contact for healthcare professionals, pharmacies, authorities, customers and consumers, handling complex scientific and product-related enquiries, quality complaints and safety information, and ensuring appropriate follow-up.
• Manage local regulatory activities related to product launches and lifecycle changes, including Health Authority submissions, translations, labelling, artwork and implementation of local regulatory requirements.
• Oversee local pharmacovigilance activities, acting as Local PV Contact and authority-facing representative, including safety case reporting, adverse events, literature monitoring, reconciliation, signal-related activities and compliance with GVP requirements.
• Ensure compliance with local regulatory and quality requirements, supporting deviations, change controls, risk assessments, product returns, temperature excursions and local SOP compliance in alignment with the Global Quality Management System.
• Review and approve promotional materials and claims, ensuring scientific accuracy and compliance with applicable regulatory, PV and promotional requirements, while acting as a regulatory and scientific sparring partner to commercial teams.
• Support regulatory inspections, PV and quality audits and inspection readiness, including follow-up actions, training and implementation of corrective measures where required.
• Support local regulatory and compliance requirements for Medical Devices, including applicable registrations, database requirements and local representative activities.
• Oversee quality and compliance activities with 3PLs, customers, distributors and service providers, including qualification/requalification, audits and agreements, while maintaining effective communication with relevant Health Authorities and Global teams.

Kenntnisse

Regulatory affairs

Pharmacovigilance

GVP

Quality compliance

Scientific affairs

Ausbildung

University degree in Medicine, Pharmacy, Veterinary medicine, Biology, Chemistry, or a comparable scientific discipline

Jobbeschreibung

Karo Healthcare, a dynamic and growing personal-care retail company, is all about making smart choices for everyday healthcare. With a wide-ranging portfolio across seven categories including medical products, we own and sell over 80 brands in about 90 countries. Our portfolio includes such brands as E45, Pevaryl, Lamisil, Nutravita, Decubal and many others. Our core belief in empowering people to make intelligent health decisions drives our growth strategy, blending organic expansion and M&A.

Join us at Karo Healthcare on our exciting journey. We're currently looking for a Scientific Affairs Specialist for our office in Düsseldorf.

What’s in it for you?

• Make real impact across 10 markets in Central Europe, working at the intersection of science, compliance, and commercial execution.
• Gain hands-on international exposure in a fast-growing, M&A-driven healthcare company with strong FMCG dynamics.
• Accelerate your development in regulatory affairs, pharmacovigilance, and product compliance within a high-performing, collaborative team.

What you’ll be doing

• Act as the local Scientific Affairs, Regulatory and Pharmacovigilance expert across Germany, providing expert guidance on local regulatory requirements, GVP compliance, product quality and patient safety across the Karo portfolio.
• Serve as a key link between Global Scientific Affairs, PV, Quality and local commercial teams, ensuring that local activities and product lifecycle management comply with applicable regulatory requirements and global standards.
• Be a key contact for healthcare professionals, pharmacies, authorities, customers and consumers, handling complex scientific and product-related enquiries, quality complaints and safety information, and ensuring appropriate follow-up.
• Manage local regulatory activities related to product launches and lifecycle changes, including Health Authority submissions, translations, labelling, artwork and implementation of local regulatory requirements.
• Oversee local pharmacovigilance activities, acting as Local PV Contact and authority-facing representative, including safety case reporting, adverse events, literature monitoring, reconciliation, signal-related activities and compliance with GVP requirements.
• Ensure compliance with local regulatory and quality requirements, supporting deviations, change controls, risk assessments, product returns, temperature excursions and local SOP compliance in alignment with the Global Quality Management System.
• Review and approve promotional materials and claims, ensuring scientific accuracy and compliance with applicable regulatory, PV and promotional requirements, while acting as a regulatory and scientific sparring partner to commercial teams.
• Support regulatory inspections, PV and quality audits and inspection readiness, including follow-up actions, training and implementation of corrective measures where required.
• Support local regulatory and compliance requirements for Medical Devices, including applicable registrations, database requirements and local representative activities.
• Oversee quality and compliance activities with 3PLs, customers, distributors and service providers, including qualification/requalification, audits and agreements, while maintaining effective communication with relevant Health Authorities and Global teams.

• University degree in Medicine, Pharmacy, Veterinary medicine, Biology, Chemistry, or a comparable scientific discipline

• 4+ years’ experience in Regulatory Affairs, Quality, or Scientific Affairs within healthcare
• Experience with pharmacovigilance processes, safety case reporting, and GVP requirements
• Solid understanding of product compliance, product lifecycle management, and health authority interactions
• Experience reviewing marketing materials and promotional claims for compliance
• Experience with local submissions and dossier handling
• Experience with authority-facing pharmacovigilance communication
• Experience delivering pharmacovigilance or compliance training
• Comfortable working cross-functionally with affiliates, distributors, and local commercial teams in an international, fast-moving organization
• Fluent in English and German

• Opportunity to create, grow, and encourage
• Flexible schedule, hybrid model with the primary work place in the office, and life-work balance
• Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
• Very positive work environment in a dynamic, international, and motivated team
• Start-up spirit while being a part of the large international organization with strong values

Karo Healthcare has a Diverse & Inclusive environment. We are looking for qualified candidates irrespective of gender, gender identity, sexual orientation, ethnicity, race, religion, national origin, disability or age.