Regulatory Affairs Manager

Beyond Trend; Germany (OH); On-site; USD 69,000 - 104,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive benefits package

Career growth opportunities

Dynamic work environment

Job summary

A leading pharmaceutical company is seeking a Regulatory Affairs Manager with a strong background in quality assurance and distribution. The role involves supervising a national approval team, ensuring compliance with EU regulations, and managing CAPAs. Candidates should have at least 5 years of relevant experience and excellent organizational skills, alongside a degree in pharmacy or a related field. Competitive salary and benefits offered.

Qualifications

• Minimum 5 years of relevant experience.
• Good knowledge of English.
• Experience in the pharmaceutical industry.

Responsibilities

• Supervision and motivation of national approval team members.
• Creating an inspiring team environment with open communication.
• Ensuring CAPAs are identified and temperature control of medicines.
• Ensuring compliance with EU GDP standards.
• Maintaining required documentation and licenses.
• Co-ordinating with manufacturers and recalling operations as needed.
• Audits of suppliers and customers as per procedures.
• Ensuring self-inspections with planned programmes and corrective actions.
• Approve returns to saleable stock and support Distribution Operations review meetings.

Skills

Analytical mindset

Excellent organization

Interpersonal skills

Problem-solving abilities

Attention to detail

Education

Graduation in pharmacy or relevant degree

Tools

MS Office

Job description

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