The Regulatory Affairs Professional will be responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements. The holder of this position will organize regulatory information, track and control submissions and provide guidance and advice to internal stakeholder.
Main Responsibilities & Tasks:
support the BioA business regarding regulatory requirements specific focus on Biological reagents and respective regulations globally relevant
Provide expert regulatory input to strategic decision making
Support the development and establishments of policies and standards
coordinates successful submissions and approval of application
Coordination with Global LPS and Corporate functions regarding compliance aspects
specific focus on product compliance checks during NPI activities
verifies process adherence to LPS standards
Keep up to date with changes in regulatory legislation and guidelines specifically related to biological substances.
activly participates in the Sartorius LPS compliance network
Qualifications & Skills:
- Bachelor degree in a science or related field
- 5+ years relevant experience within the Regulatory Affairs discipline
- Deep knowledge of the relevant Regulatory requirements
- Thorough understanding and demonstrated ability to apply Regulatory guidelines/regulations
- ability to develop innovative strategies and creative solutions within the Regulatory context and within the scope of requirements/available resources
- Proven analytical skill and technical/scientific competence
- Attention to details and ability to appropriately assess risks
- Strong initiation and organizational skills
- Excellent communication skills, with ability to influence others and negotiate successful outcomes
- Proactive, quick learner and independent worker able to effectively multi-task in a strongly growing organisation
- Team-player, able to positively influence Team members at all levels
Driving our future growth requires talented people. Sartorius is a dynamic organization suited to people who want to showcase skills, be recognized for expertise and thrive in a vibrant and innovative environment.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex or national origin. We are also an equal opportunity employer of individuals with disabilities and protected veterans.
Please view equal employment opportunity posters provided by OFCCPhere
We look for employees who would like to grow with us and move the innovative life sciences sector forward. In the process, we focus on agile project work, mutual support within teams and working as equals. Sartorius thrives as a company with people who give their very best every day and who are eager to develop personally and professionally.
Further insightsinto our world of work can be found
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin. We are also an equal opportunity employer of individuals with disabilities and protected veterans.
