Regulatory Affairs Manager

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 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.

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