Your opportunity at an international company in the pharmaceutical industry!

Our client, a leading company in the pharmaceutical industry, is looking to strengthen its team in Frankfurt am Main and is seeking a full-time Regulatory Specialist (m/f/d) – Pharma / CMC to start as soon as possible.

 

• 2 days per week remote work possible
• 37.5-hour work week with flexible working hours
• Attractive compensation package

 

Submit your application easily via our online form – we look forward to hearing from you!

Your responsibilities

• Review internal procedures to ensure alignment with current regulatory authorizations
• Analyze operational updates to assess potential regulatory considerations
• Coordinate regulatory planning and execution at the site level in alignment with broader organizational frameworks
• Enable cross-functional awareness of global regulatory milestones to support operational readiness
• Offer strategic input for technological upgrades and process optimizations from a regulatory perspective
• Support documentation transfer and adaptation efforts for established products across various markets
• Prepare technical documentation in accordance with regulatory submission standards and language consistency
• Contribute to global authorization processes by assembling technical content and compliance documentation
• Oversee the handling of inquiries and follow-up actions related to regulatory submissions
• Develop formal responses to health authority communications in collaboration with technical teams
• Maintain alignment between site operations and regulatory functions at regional and global levels
• Identify and implement opportunities to enhance regulatory workflows and reduce complexity
• Provide functional expertise during compliance assessments and regulatory inspections
• Utilize digital platforms to manage documentation and support process development initiatives

Qualifications and skills

• Pharmaceutical background involving laboratory, manufacturing, or analytical control preferred
• Regulatory CMC experience, ideally between one and five years
• Understanding of global regulations and awareness of health authority and industry developments advantageous
• Strategic problem-solving skills for complex technical and regulatory issues
• Demonstrates initiative, independent decision-making, and forward-thinking
• Effective communication with internal teams and external stakeholders
• Familiarity with chemical and biological product types desirable
• Experience with internal data management and documentation systems required
• Strong proficiency in both written and spoken German and English highly recommended

What you can expect

• Hybrid work model and flexible working hours
• Permanent employment contract
• Transparent opportunity for direct placement with the client
• Competitive remuneration package, including bonus payments such as holiday and year-end bonuses
• Well-structured and thorough onboarding process
• Dedicated personal support throughout the assignment
• Access to exclusive employee discounts through established partner programs
• Exposure to leading international companies and corporate environments

Contact

Your point of contact for this position

Eirini Chrysafidou
HR Consultant

069-13872922
eirini.chrysafidou@permacon.de

Permacon GmbH
Mainzer Landstraße 181
60327 Frankfurt