Job Description
We are currently looking for a Regulatory Affairs Specialist - Raw Materials Compliance (x|f|m) for the Regulatory Affairs Pharma & Systems department within Sartorius Stedim Biotech GmbH at our headquarters in Goettingen (full-time, with the possibility to work some days remotely).
The overall goal for the owner of this role will be to make sure, that applicable standards are properly being used in our end-to-end activities. This will contribute to full compliance of products being placed on the market. The team consists of ten members and is looking forward to shaping the future with you.
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Manage all Regulatory Affairs activities ensuring appropriate and effective regulatory documentation
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Provide expert regulatory input to strategic decision makers, including review, prioritization, and external communications
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Support the development and establishment of procedures, policies and standards
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Creation and renewal of technical documentation and health certification dossiers such as related statements
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Raise regulatory strategy for new projects
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Maintenance of animal-by-products data
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Liaise and negotiate with regulatory authorities, if needed
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Provide advice about regulations and their requirements to relevant stakeholders
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Review and report the overall quality status
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Keep up to date with changes in regulatory requirements, legislation and guidelines
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Establishing and maintenance of data bases
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Successfully completed Master's degree in Chemistry, Biotechnology, Pharmaceutics, Food Technology or a comparable scientific field
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Several years of relevant experience within the regulatory affairs discipline in a manufacturing environment, experience in pharma or medical device industry
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Deep knowledge of chemistry for devices or products in the above listed areas
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Thorough understanding and ability to apply regulatory guidelines and regulations related to medical devices or products related to biotechnology and pharmaceutical industry
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Ability to develop innovative strategies and creative solutions within the regulatory context
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Proven analytical skills and technical competence meet strong initiation and organizational skills
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Attention to details and ability to appropriately assess risks
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Excellent communication skills, with ability to influence and negotiate a successful outcome
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Proactive, quick learner and independent worker
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Fluent in English, German will be a plus
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Identification with our values: Sustainability, Openness & Enjoyment
A s a growing global life science company, stock listed on the DAX and TecDAX, Sartorius offers a wide range of benefits:
- Personal and Professional Development: Mentoring, leadership programs, Talent Talks, LinkedIn Learning, internal seminar offerings, coaching for managers
- Work life balance: Remote options, flextime, flexible work schedules, sabbaticals
- Travel benefits: Car leasing, bike leasing, large free parking garage, good bus connections
- Welcoming Culture: Mutual support, teamspirit and international collaboration; communities on numerous topics, such as coaching, agile working and businesswomen network