Job Description

Overview Job Title - Regulatory Affairs Manager Terms - Full Time Role Salary - Competitive Job Timings – 8 AM to 5 PM Requirements - Graduation in pharmacy background or any relevant degree About the role Supervision and motivation of national approval team members Contact person for all team members Proactively ensuring smooth team operations and effective collaboration Responsibilities Creating an inspiring team environment with an open communication culture and ensuring the management of authorised activities and quality records are maintained accurately CAPA, Deviation, SOP drafting, training of the team, supplier audits Co-ordinating with manufacturers and promptly performing any recall operations Conducting supplier and customer audits as per the procedures Ensuring self-inspections are performed at appropriate regular intervals with prearranged programmes and implementing corrective actions Ensuring and approving final disposition of returned, rejected, recalled or falsified products Approve returns to saleable stock and provide quality support and oversight for Distribution Operation review meetings with Distribution contractors Contribute to defining GDP, quality, KPIs and OT review quality indicators with recommendations for improvements related to GDP guidelines Ensuring CAPAs are identified, temperature control of medicines, and temperature mapping Ensuring annual GDP, initial and continuous training is implemented and maintained for all employed staff Ensure Quality Technical Agreements are in place for outsourced activities and with subcontractors Ensure that Parallel Import design and relabeling comply with EU GDP standards Maintaining required documentations and licenses for processing these licenses Extensive experience in the pharmaceutical industry, with a strong background in distribution or quality assurance Thorough understanding of German and EU regulations pertaining to pharmaceutical distribution, including GDP requirements Excellent organizational skills with keen attention to detail and accuracy Strong interpersonal and communication abilities, with the capacity to collaborate with internal and external stakeholders Ability to work autonomously, manage multiple priorities, and make informed decisions in a dynamic environment Candidate Requirements Minimum 5 years of relevant experience An analytical and problem-solving mindset Excellent organization and time management skills Commercial or pharmaceutical training Good knowledge of English Confident use of MS Office Ability to work in a team Flexibility and commitment; forward-thinking Benefits Competitive salary and performance-based incentives Comprehensive benefits package including health insurance Opportunities for career growth and advancement within a global organization Dynamic and collaborative work environment with a diverse and inclusive culture #J-18808-Ljbffr

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