Senior Regulatory Affairs Manager
Glycom is a rapidly growing Danish biotechnology company dedicated to the scientific, clinical and commercial development of Human Milk Oligosaccharides for a broad range of health applications that can impact human health worldwide. Our Danish operations include world class R&D facilities, large scale manufacturing and advanced business development. We employ a diverse and highly dedicated team. Further, we are continuously opening markets for new applications for HMOs. Our latest brand, Holigos™ is a medical food for the millions of people suffering from IBS.
Our leading HMO products are approved in the EU and the US and are available globally in Nestlé infant formulas. We continuously seek approvals in further global markets, additional applications and for new ingredients.
The job and ideal candidate
We are looking for an ambitious Senior Regulatory Affairs Manager with strong scientific background and experience in food regulatory affairs.
The ideal candidate fulfils the following expectations:
- Holds a degree (MSc or PhD) in a scientific discipline related to nutrition, food science, toxicology or biotechnology. Additionally, a degree in food regulatory affairs (PgDipl, BSc or MSc) would be an advantage
- Has several years of practical experience in related fields (e.g. regulatory affairs, toxicology, food legislation, scientific or medical writing, governmental food authorities)
- Possesses demonstrated excellent scientific writing skills
- Possesses multidisciplinary understanding of science, technology and legislation
- Possesses strong project management skills necessary for leading complex projects from conception to conclusion
- Excellent stakeholder management skills to build and maintain the day-to-day relationships and communication with internal and external organizations
- Possesses excellent Microsoft Office and general software skills (experience with SharePoint or other data management systems is a Plus)
- Is fluent in English and has strong interpersonal skills to collaborate with people on all levels and from different cultural backgrounds.
You are a team player, have drive and tenacity, and can work in a structured and systematic way to tight deadlines whilst keeping a cool head and a positive approach.
You will report to the Head of Regulatory Affairs and your key responsibilities are listed below.
Responsibilities will include:
- Identify and assess regulatory risks associated with product development and define plans with project teams to mitigate the risks
- Maintain an awareness of new and developing legislation, regulatory policy and regulatory guidance relating to food and food ingredients, mainly in the EU
- Prepare or delegate regulatory dossiers for food and food ingredient submissions globally
- Interact with analytical and project teams to understand, assess and collect information relevant to regulatory submissions
- Support data and document archiving relevant to regulatory applications
- Initiate and supervise external work (mostly of analytical nature) to fill data gaps.
Other tasks may be applicable according to candidate’s skillset.
Salary and terms of employment
We are the world leader in the production, regulatory approvals and the applications of Human Milk Oligosaccharides and we enable our employees to develop their skills by interacting with best in class stakeholders and organizations. For candidates with strong leadership drive we offer extensive career development opportunities. In addition, we offer a competitive salary and health benefit package. Worldwide travel can be expected for up to 30 days a year. You will be based in Scion DTU Science and Technology Park in Hørsholm (20 km North of Copenhagen).
Please apply by sending a brief application and a CV to: firstname.lastname@example.org.
We would like to welcome you on board as soon as possible.
In case of questions, please contact HR Manager Dorota Hawkin by email email@example.com or by phone +45 6151 1133.