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

⚫ 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.

⚫ 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

⚫ 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