Regulatory Affairs Director

14-6-2019 gent
company profile

Working for Rousselot / Darling lngredients means working for an ambitious industry leader in an entrepreneurial and no-nonsense industrial environment where 'best in class' is the standard. lf you can make a difference in the development and growth of our company, choose Rousselot / Darling lngredients for a challenging career.

With more than a century of experience, Darling Ingredients is the world's largest producer of sustainable natural ingredients from edible and inedible organic residuals. Headquartered in Irving, Texas, and with an international head office in Son, The Netherlands, we are the only publicly traded company in our industry (NYSE/DAR). With approximately 10,000 dedicated employees globally and a strong presence in North America and Europe we are one of the largest companies in the industry. A pioneering innovator in repurposing, we create a wide range of products and customized specialty solutions for the food, feed, pet food, fuel and other industries at plants in over 200 locations on five continents. Rousselot is a brand of Darling Ingredients.

Rousselot is the global leader of gelatin and collagen peptides. Rousselot recently launched X-pure, which is a low endotoxin gelatin/collagen for in body biomedical applications. We work in partnership with our customers all over the world, delivering innovative and advanced ingredient solutions manufactured through state of the art operations. We help our customers achieve their goals, enabling them to create world class pharmaceutical, food and nutritional products to inspire and excite today’s demanding consumers.

Interested? Apply via anneleen.vanbuggenhout@cx.ausy.be or call 03 369 65 88 for more information.

job description

RA Director and looking for a new challenge? Take a look here!

The Global Regulatory Affairs Director Rousselot is responsible for global regulatory compliance, relationships with authorities and industry federations and communication with and support of customers and sales team. The purpose of the job is ensuring regulatory compliance globally, specifically of sourcing, production, logistics (import-export), New Product Developments and commercial activities for all Rousselot products.


As Regulatory Affairs Director you will be responsible for:


1. Global Regulatory Compliance

  • Ensure compliance of products, process, raw materials with all feed, food, pharma & medical regulations, including product & plant registrations
  • Actively involved in New Product Development (NPD) and authorizations (feed/food/nutritional/pharma/medical products)
  • Crisis management and prevention by identification of possible risks such as contaminants and animal diseases
  • Organization of the regulatory survey with any relevant sources such as EU and US (FDA, USDA) databases and consultants
  • Coordination of regulatory topics with Rousselot teams worldwide (Europe, China, USA, South America)
  • Create solid team to discuss common regulatory topics and sharing info


2. Building relationships with authorities and industry federations:

  • Member of the GME regulatory committee and national/regional food association(s)
  • Work closely with relevant local authorities (food, agriculture, pharmaceutical) and local Rousselot teams on regulatory topics involving Rousselot factories
  • Strive to reduce trade barriers in coordination with GM associations and authorities


3. Communication with and support of customers and sales team:

  • Direct regulatory contact with key customers globally and EU specifically
  • Provide all regulatory information to sales force, technical support and quality managers
  • Support any regulatory questions coming from customers, “regulatory hot line”
  • Develop information for customers: meetings, regulatory newsletter, specific statements
  • Support (pharma) customers on certification and export of the gelatins

your contribution

  • Master's degree

  • Regulatory affairs experience in the pharmaceutical, (bio)medical industry and/or food industry
  • Fluent in English
  • Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance
  • Ability to develop innovative strategies and creative solutions within the regulatory context within the scope of global requirements and available resources
  • Willingness to travel 20% of the time in Europe and overseas.



what do we offer?

  • Working in a people-oriented, international and dynamic culture.
  • International experience and exposure, due to the multitude of contacts with
  • people in our business units, with different cultures all over the world.
  • Development of personal skills and knowledge, due to a wide variety of tasks and
  • responsibilities.
  • Training and education programs as deemed relevant for further development.
  • Independence and the opportunity to initiate or participate in advisory projects for implementing solutions in close cooperation with key stakeholders.

summary
function
project manager (m/f)
employment type
full time
contract type
immediate permanent employments
reference
CXRSP-82350
your Randstad contact
Anneleen Vanbuggenhout
anneleen.vanbuggenhout@cx.ausy.be 03 369 65 88
03 369 65 88