knoell is one of the leading global service providers in offering regulatory registration, clinical development and product development support to clients. Our team of scientific and regulatory experts and extensive network of partners ensures that all the different regulatory requirements are right from the project outset to support our client’s global business. People are at the heart of our family-owned business and our values guide the way to our success. Team spirit and mutual support are very important to us. Our culture is characterised by strong international co-operation, can-do attitude, focus on quality and a growth mindset.
Our strength is to be where it matters - think globally, act locally!
Regulatory Affairs Manager, FFCM (f/m/d)
This role can be based in the following countries: Austria, Germany, Croatia, France, Spain, Netherlands, Portugal, Poland and the United Kingdom.
JOB OVERVIEW
As a Regulatory Affairs Manager, Food and Food Contact Materials Division, you will be responsible for the project management of food contact compliance and notification projects, and the implementation of such projects based on global regulatory knowledge and experience in the food and food contact service area.
YOUR TASKS
- Support the registration process of new food contact substances or novel foods according to national and international regulatory requirements, by using up-to-date know how on the relevant regulations as well as regulatory processes, costs, and timelines
- Conduct global regulatory compliance assessments via interpretation of existing food and/or food contact regulations and searches of regulatory databases
- Develop the regulatory strategy for obtaining compliance by interpreting existing regulations and understanding what information is required to complete food contact or food products assessments globally
- Assist in authoring EFSA Dossiers, Food Contact Notifications (FCNs), and Global Food Contact Petitions
- Communicate with Authorities in the jurisdiction where the relevant regulatory submission will be made
- Manage projects by using your communication and organisational skills together with your regulatory expertise
- Assure that the work done in your projects in the FFCM area is in line with current regulatory guidance and follows our internal project standards. Adhere to project management rules at knoell and using dedicated project management tools
- Author compliance reports, third party certification letters for compliance, and/or statements of safe use
- Project manage food contact projects or food products projects from first client contact to completion
- Review and provide comments on peer authored compliance reports
- Work toward becoming a subject matter expert in a dedicated topic in the regulatory area of FFCM: You will build-up, maintain and share practical knowledge in a growing, team-oriented working group by frequently contributing to discussions in our established communication channels and meetings
- Liaise with internal toxicologists in order to complete compliance projects
- Liaise with external analytical laboratories in order to work toward compliance and notification project completion
- Become familiar with conducting dietary exposure calculations
- Deliver projects in the timeline agreed to with the client
- Responsible for keeping up to date on the dynamic food and/or food contact regulations through seminars and networking events
- Participate in conference calls and web meetings with clients to understand client needs.
YOUR PROFILE
- Minimum BS/MS Degree in a scientific discipline (preferably Chemistry, Biochemistry, and/or Polymer Science)
- Minimum 3 years of experience in Food and/or Food Contact Regulatory Affairs, including conducting regulatory compliance reviews for food and/or food contact materials
- Experience in using regulatory databases to conduct compliance reviews
- Familiar with the knowing what a Food Contact Notification and/or Global Food Contact Petition is
- Excellent project management skills
WHAT WE OFFER
- Work in a dynamic family-owned business environment with an international team in which new ideas, creative approaches, and collaboration are valued.
- You will have the opportunity to work with market leaders in our industry.
- Development is core, and at knoell we offer various opportunities to support your personal, leadership and technical development, including English language courses to help you effectively communicate in our business language.
- knoell offers a flexible working policy and is a remote-first company, where you have the flexibility to work from home, at our headquarters in Mannheim or at one of our local offices based in your location.
- Part-time work options are generally supported on request subject to meeting business requirements.
- It is important to us that you have both a career and personal life - we celebrate the work-life balance of our colleagues.
- At knoell we have a global employee referral program as part of the recruitment process where you can actively participate and get rewarded for referring talent to knoell.