BrightOwl Loader Loading

Regulatory Manager - United States  

Company managed [?] Still accepting applications

Posted on : 13 August 2017

Project Description

Pioneer a brighter future

When you join Novozymes, you’ll lead the way to create a brighter future. To realize your full potential, you’ll be supported by your colleagues who share the same goals and ambitions as you. Help us rethink tomorrow to change the world and the way people live and work.

Regulatory Specialist / Regulatory Manager for Animal Health and Nutrition (AH&N)

As a world leader in biotechnology, Novozymes plays center stage in building a sustainable bio-based economy. As our Regulatory Specialist / Manager for AH&N / direct fed microbial, you will apply your extensive experience in this area toward helping Novozymes in achieving our ambitious goals. You will join our diverse regulatory affairs team at our North American Headquarters in NC and become our expert in the AH&N area. You will lead the design and execution of regulatory programs and procedures together with our partners and key customers to ensure regulatory compliance and legal sale of all Novozymes’ microbial products for this area in North America. You will contribute to developing successful new product development strategies. Your strong impact will be enabled through the solid connections you will make cross-functionally with global internal colleagues and by leveraging your existing network within trade associations and partners. Although your focus will be on microbes for AH&N / direct fed microbial, you will also be expected to bring and apply your solid understanding of enzymes toward advancing programs in the animal feed area as well.

For this position, you will need to have:
  • MSc or equivalent in science (biotechnology, biology, microbiology, agricultural science, veterinary science or related field)
  • Several years of RA experience from relevant industry or authority, most preferably in the AH&N or veterinary area
  • Solid understanding of the regulatory aspects surrounding the approval of vaccines and pharmaceutical drugs, and feed ingredients
  • Ability to work at a strategic level and to translate legislation into company product related requirements
  • Several years’ experience in working with cross disciplinary projects in an international setting
  • Strong communication, organizational, and teamworking skills, ‘can-do’ attitude, and able to work in a structured and systematic manner across diverse culture
  • Strong project leadership and stakeholder management skills
  • Ability to deal with confidential information
  • Experience from engaging with trade organizations and authorities to influence legislation (e.g. AAFCO, FDA, AFIA)
  • Experience with consultants and partners for addressing regulatory challenges and potential acquisitions
  • Ability to travel within North America as well as international travel (15%) with periodic trips to Copenhagen, Denmark required
Application Deadline: September 8, 2017

About Novozymes
Novozymes is the world leader in bio-innovation. We create tomorrow’s solutions by applying technology to nature, to the benefit of both our customers’ bottom line and the planet. Novozymes serves a broad array of industries using enzymes, microorganisms, biopolymers, and biopharmaceutical ingredients. With over 700 products in 130 countries, Novozymes’ bio-innovations improve industrial performance and safeguard the world’s resources because they represent superior and sustainable solutions for tomorrow’s ever-changing marketplace.

Novozymes is committed to creating a diverse environment and is proud to be an equal opportunity and affirmative action employer. All employment decisions are based on business needs without regard to race, color, ethnicity, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, disability or veteran status.