Regulatory Affairs Specialist

Gnosis

  • Desio, Monza Brianza
  • Tempo indeterminato
  • Full time
  • 7 giorni fa
  • Candidati facilmente
Company DescriptionFor over 30 years, Lesaffre has been involved in Human Health & Nutrition as part of its ambition to Better Nourish and Protect the Planet. In November 2018, Lesaffre acquired Gnosis Advanced Biotech and officially combined it with Lesaffre Human Care to form a new Business Unit named Gnosis by Lesaffre.At Gnosis by Lesaffre, we are committed to cultivating and to delivering nutritional actives, probiotics, and nutritional and functional yeasts that benefit human health and wellbeing, thanks to the power of microorganisms and biotransformation processes like fermentation. Put differently, we explore life to improve living.Our vision: At Gnosis by Lesaffre, we strive for a world that moves better, digests better, ages better, feels better, and, ultimately, lives better thanks to microorganisms and biotransformation.Job DescriptionAt Gnosis by Lesaffre, we are looking for a talented, dynamic, and motivated Regulatory Affairs Specialist to support the expansion of our business. You will be responsible for the regulatory compliance of our product portfolio and play a critical role providing strategic advice on regulatory risks and opportunities to support market growth and innovation.Responsibilities
  • Ensure compliance of assigned Gnosis’ product portfolio with local regulations,
  • Manage timely regional registration activities, including registration dossier preparation and proper documentation of submitted documents,
  • Execute regional regulatory strategies in line with the global strategic plan,
  • Provide regulatory guidance and advice to internal stakeholders (e.g. marketing, R&D),
  • Conduct regulatory watch and monitor changes in local legislation landscape, assess the impact towards Gnosis’s product portfolio and communicate accordingly to internal stakeholders,
  • Build effective working relationships with internal stakeholders,
  • Work closely with regulatory colleagues to maintain knowledge in local regulations and product-specific regulatory requirements,
  • Maintain full awareness of regulatory activities of assigned portfolio and provide regular reports.
Qualifications
  • Bachelor’s degree or equivalent in Science, Pharmacy or related scientific discipline
  • Minimum of 2 years of regulatory experience in healthcare or food industry.
  • Knowledge in food/food supplements in EU/US, experience with EFSA regulations is a plus,
  • Good organizational skills, possess structured approach to working tasks,
  • Collaborative team player with the ability to work independently,
  • Experience in project management appreciated, however project management course will be offered,
  • Comfortable working in an international fast paced environment,
  • Good written and verbal communication skills,
  • Fluent in English is a must.
Additional Information
  • The job is based in Desio (MB) - Italy
  • Full-time contract
  • Possible Smart-Working after trial period
  • Be part of a growing company
  • Work in a dynamic international environment
  • We are a successful family-owned company with long-standing history where people truly matter.
  • We promote a sense of fulfilment with a genuine mission: nourish and protect the planet.
  • An opportunity to work in a real international environment.
At Lesaffre, diversity is a strength that enriches our culture and our teams. We are committed to offering you a work environment where you can thrive, regardless of your background, gender, age or abilities. We encourage all applications, as we believe that diverse perspectives strengthen our ability to innovate and meet the challenges of tomorrow.

Gnosis