Goettingen, Germany
7 days ago
Regulatory Affairs Specialist - Raw Materials Compliance (x|f|m) - Hybrid
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.

Grow with us – Your Responsibilities

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

What will convince us

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

What we offer

As 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

About Sartorius 

Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. 

We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.

Join our global team and become part of the solution. We are looking forward to receiving your application. 
www.sartorius.com/careers

Confirm your E-mail: Send Email
All Jobs from Sartorius Corporation