Regulatory Affairs Professional Jobs

What you will accomplish together with us:

• Support new products development and acquisition of new product scopes.
• Supports in compliance of products in different destination countries.
• Preform successful submissions and approval of applications.
• Liaise and negotiate with regulatory authorities.
• Provide regulatory support to customers.
• Support the development and establishment of policies and standards.
• Create technical files for regulatory submissions and products registration.
• 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.
• Keep up to date with changes in regulatory legislation and guidelines.
• Executing regulatory affair policy and ensuring the implementation of appropriate and effective regulatory strategies.
• Provide advice about regulations to relevant internal customers.
• Provide expert regulatory input to strategic decision making, including review, prioritization, and external communications.

What will convince us:

• 8+ years relevant experience within the Regulatory Affairs discipline
• Attention to details and ability to appropriately assess risks.
• Thorough understanding and demonstrated ability to apply Regulatory guidelines/regulations.
• Identification with our core values: Sustainability, Openness, Enjoyment
• Ability to develop innovative strategies and creative solutions within the Regulatory context and within the scope of requirements/available resources.
• 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.
• Deep knowledge of the relevant Regulatory requirements
• Team-player, able to positively influence Team members at all levels.
• Proven analytical skill and technical/scientific competence.
• Bachelor's degree in a science or related field
• Strong initiation and organizational skills

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:

• 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.
• Work-life balance: Working from home at many sites
• 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
• We offer a comprehensive array of benefits which include: Paid Vacation (3 weeks), 7 sick days (eligible to carry over up to 30 days), 11 Corporate Holidays, 2 Floating Holidays, Community Service Day, Medical, Dental, Vision, Company Paid and Supplemental Life Insurance, STD & LTD, 401k (with generous company match), Tuition Assistance, Flexible Spending Accounts, Employee Assistance Program, Health and Wellness Program (in addition to other benefits).
• Intelligent working environment: working in smart buildings with the latest technology and equipment

All qualified applicants will be considered 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.

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We look forward to receiving your application.

www.sartorius.com/career