Overview
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 and ensuring 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 supplier and customer audits as per the procedures
- Ensuring self-inspections are performed at appropriate regular intervals with prearranged programmes and implementing corrective actions
- Ensuring and approving final disposition of returned, rejected, recalled or falsified products
- Approve returns to saleable stock and provide quality support and oversight for Distribution Operation review meetings with Distribution contractors
- Contribute to defining GDP, quality, KPIs and OT review quality indicators with recommendations for improvements related to GDP guidelines
- Ensuring CAPAs are identified, temperature control of medicines, and temperature mapping
- Ensuring annual GDP, initial and continuous training is implemented and maintained for all employed staff
- Ensure Quality Technical Agreements are in place for outsourced activities and with subcontractors
- Ensure that Parallel Import design and relabeling comply with EU GDP standards
- Maintaining required documentations and licenses for processing 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 keen attention to detail and accuracy
- Strong interpersonal and communication abilities, with the capacity to collaborate 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