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
Interested in the role of Regulatory Specialist (m/f/d) – Pharma / CMC?
Apply now via our online application form!