Pharma Regulatory Affairs Lead Quality & Compliance

Job Description 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 To ensure 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 the suppliers and customer audits as per the procedures · To ensure that the self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place. · To ensure and approve final disposition of returned, rejected, recalled or falsified products are dealt with effectively. · Approve any returns to saleable stock, providing quality support and oversight for Distribution Operation review meetings with Distribution contractors. · Contribute to defining GDP, quality, KPI's and OT review quality indicators with recommendations for actions for improvement in regard to GDP guidelines. · Ensuring CAPA's are identified, effective temperature control of medicines, temperature mapping. · Ensuring annual GDP, initial and continuous training programmed are implemented and maintained to all employed staff. · Ensure Quality Technical Agreements are in place for all outsourced activities and with all subcontractors. · Ensure that the Parallel Import design and relabeling is according to the EU GDP standards · Maintaining required documentations and licenses for the processing of 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 a keen attention to detail and accuracy. · Strong interpersonal and communication abilities, with the capacity to collaborate effectively 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