Regulatory Affairs Manager

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 authorized 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 programmes 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 relabelling 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.