Regulatory Affairs Manager
- Employer
- Proclinical Staffing
- Location
- Hessen, Frankfurt am Main, Germany
- Salary
- Negotiable
- Start date
- 1 Jul 2020
- Closing date
- 15 Jul 2020
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Management
Job Details
A biotechnology company in Frankfurt are looking for a bright and talented Regulatory Affairs Manager to assist with clinical projects. The individual will be able to step up and help the organisation make life changing improvements to medicine.
Job Responsibilities
- Provide responses to regulatory agencies regarding product information or issues Train staff in regulatory policies or procedures Manage activities such as audits, regulatory agency inspections, or product recalls Participate in the development or implementation of clinical trial protocols Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced Communicate regulatory information to multiple departments Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes Oversee documentation efforts to ensure compliance with domestic and international regulations and standards Monitor regulatory affairs activities to ensure that they are aligned with corporate sustainability or green initiatives
Skills and Requirements
- Degree in life science, medicine or pharmacy Min. 2 years of experience in pharmaceutical environment Very good command of English (both oral and written), as well as German Thorough knowledge of guidelines Problem-solving skills Self-driven and structured/organized Strong presentation skills
To Apply
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Nico Kohlwes on +49 69 94189257 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.
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#Clinical
Company
At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.
Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives.
ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating.
Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.
- Website
- https://www.proclinical.com/
- Telephone
- 0800 988 4437
- Location
-
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom
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