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