You oversee regulatory compliance for clinical trials, ensuring high-quality execution while collaborating with teams and preparing the necessary documentation for inspections and audits.
Anforderungen
- •Bachelor's degree in life sciences
- •4 years experience in Regulatory Affairs
- •Experience with oncology studies is a plus
- •Excellent knowledge of clinical trial processes
- •Understanding of ICH-GCP regulations
- •Experience with EU CTR is a plus
- •Excellent organizational and planning skills
- •Ability to manage multiple competing priorities
- •Critical thinking and risk analysis
- •Good negotiator and communicator
- •Strong interpersonal and analytical skills
- •Proficient in MS Excel and MS PowerPoint
- •Fluent in English with excellent skills
- •Good level of German
Deine Aufgaben
- •Oversee regulatory aspects of global clinical trials.
- •Ensure high-quality execution across studies and vendors.
- •Develop and review clinical trial documents.
- •Respond to Agency requests according to standards.
- •Ensure compliance with regulatory requirements and guidelines.
- •Collaborate with cross-functional teams for trials.
- •Coordinate Health Authority interactions as needed.
- •Contribute to SOP development and process improvement.
- •Ensure accurate documentation and inspection readiness.
- •Participate in internal audits and Health Authority inspections.
Deine Vorteile
Creative teamwork
Short communication channels
Dynamic work environment
Open corporate culture
Limited travel requirements
Two home office days
Original Beschreibung
## (Senior) Manager Regulatory Affairs (f/m/d)
###### Permanent employee, Full-time ·Planegg-Martinsried
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##### Your mission
* Oversee regulatory aspects of several clinical trials on a global/regional level in the field of immune-oncology therapies. Ensure consistent, high-quality execution across studies and vendors within regulatory requirements.
* Oversee the development and review of clinical trial documents, and responses to Agency requests in alignment with regulatory and ethical standards and the development of portfolio documents.
* Ensure compliance of assigned clinical studies with regulatory requirements, the ICH-GCP guidelines and the respective procedures (i.e., policies, SOPs, instructions).
* Collaborate with internal and external cross-functional teams for assigned clinical trials as representative for Regulatory Affairs
* Set-up and coordination of Health Authority interactions as applicable
* Contribute to process improvement and SOP development.
* Ensure accurate trial documentation and inspection readiness of assigned trials, participate in internal audits and HA inspections, and HA meetings as required.
##### Your profile
* Bachelor’s or master’s degree in life sciences with minimum of 4 years of experience in a Regulatory Affairs role within Biotech, Pharma or CRO organization; experience with oncology studies is a plus.
* Excellent knowledge and understanding of clinical trial processes, methodology and regulations (ICH-GCP, and any local regulations). Experience with EU CTR is a plus.
* Excellent organizational and planning skills; able to effectively manage multiple competing priorities, identify and solve conflicts (critical thinking and risk analysis), meet deadlines without direction.
* Good negotiator and communicator, strong interpersonal and analytical skills.
* Proficient computer skills (excellent knowledge level of MS Excel and MS PowerPoint) and fluent in English with excellent oral and written skills; good level of German.
##### Why us?
* Creative working in X-functional teams
* Short communication channels
* Dynamic and goal-orientated environment
* Open and appreciative corporate culture in a multicultural environment
* Limited domestic and international travel required, when necessary
* 2 days home office per week