Quality and Regulatory Affairs Professional

26 Oct, 2020

Jobs

Quality and Regulatory Affairs Professional

Sartorius Corp.
Bohemia, NY/Ann Arbor, MI/Albuquerque, NM/Fremont, CA

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.

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 such as EPA (FIFRA) and USDA (Animal by products) for the relevant products
  • supporting the generation of MSDS
  • supports international registration and licensing activities regarding Hazardous substances, Animal By Product and others as applicable
  • 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 specifically licenses/registrations required for export and import activities of biological products
  • 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

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.

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 insights into our world of work can be found here.

Job posted: 2020-10-26