Sartorius, a leading international partner of life science research and the biopharmaceutical industry is expanding.

Sartorius has an exciting opportunity for a dynamic,self-motivated, Regulatory Affairs Professional to be based remotely in Michigan. The incumbent in this role will be responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements within the cell culture technologies division particularly for the cell and gene therapies market.

What you will accomplish together with us: Executing regulatory affair policy and ensuring the implementation of appropriate and effective regulatory strategies. Organize regulatory information, update on current regulatory requirements and guidelines, classify products in accordance with different target countries regulation, write technical files for the different regulatory documents, list and register the products in target countries, track and control submissions and provide guidance and advice to internal and external customers. Provide expert regulatory input to strategic decision making, including review, prioritization, and external communications. Support the development and establishment of policies and standards. Create technical files for regulatory submissions and products registration. Support new products development and acquisition of new product scopes. Preform successful submissions and approval of applications. Liaise and negotiate with regulatory authorities. Provide advice about regulations to relevant internal customers. Provide regulatory support to customers. Supports in compliance of products in different destination countries. Keep up to date with changes in regulatory legislation and guidelines.

What will convince us: Bachelor's degree in a science or related field 8+ 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 organization. Team-player, able to positively influence Team members at all levels. Identification with our core values: Sustainability, Openness, Enjoyment

What we offer Sartorius' ambition is to simplify progress in the bio-pharmaceutical industry to help translate scientific findings into new therapeutics faster and more efficiently. Nearly 10,000 employees at more than 60 sites are working together on achieving our goal: Better health for more people. And together, we have grown strongly over the past years. Enjoy the advantages of working with a global player: Opportunity for international career development: a global network offering seminars and training sessions, expert and manager career paths Open and highly collaborative culture: mutual support within teams and working as equals, team spirit and international collaboration Work-life balance: Working from home at many sites Intelligent working environment: working in smart buildings with the latest technology and equipment Ambitious goals: Sartorius plans to double its sales revenue approximately every five years and expects to grow its global team to approximately 15,000 people in 2025. We offer a comprehensive array of benefits whic