Regulatory Affairs Specialist - Raw Materials Compliance (x|f|m) - Hybrid

Sartorius • Other • Göttingen • 2d ago

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.

Manage all Regulatory Affairs activities ensuring appropriate and effective regulatory documentation
Provide expert regulatory input to strategic decision makers, including review, prioritization, and external communications
Support the development and establishment of procedures, policies and standards
Creation and renewal of technical documentation and health certification dossiers such as related statements
Raise regulatory strategy for new projects
Maintenance of animal-by-products data
Liaise and negotiate with regulatory authorities, if needed
Provide advice about regulations and their requirements to relevant stakeholders
Review and report the overall quality status
Keep up to date with changes in regulatory requirements, legislation and guidelines
Establishing and maintenance of data bases

Successfully completed Master's degree in Chemistry, Biotechnology, Pharmaceutics, Food Technology or a comparable scientific field
Several years of relevant experience within the regulatory affairs discipline in a manufacturing environment, experience in pharma or medical device industry
Deep knowledge of chemistry for devices or products in the above listed areas
Thorough understanding and ability to apply regulatory guidelines and regulations related to medical devices or products related to biotechnology and pharmaceutical industry
Ability to develop innovative strategies and creative solutions within the regulatory context
Proven analytical skills and technical competence meet strong initiation and organizational skills
Attention to details and ability to appropriately assess risks
Excellent communication skills, with ability to influence and negotiate a successful outcome
Proactive, quick learner and independent worker
Fluent in English, German will be a plus
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

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