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Regulatory affairs manager

Leipzig
Hartmann Young
Manager
Inserat online seit: Veröffentlicht vor 22 Std.
Aufgaben der Stelle

Our client is an innovative, research-driven feed additive company developing next-generation solutions that improve animal health, productivity, sustainability, and feed efficiency. With a strong commitment to science, innovation, and product development, the company is recognized for bringing differentiated technologies to the global animal nutrition industry.


As a growing and agile organization, the company offers the opportunity to work in a dynamic environment where decisions are made quickly, innovation is encouraged, and individuals can have a direct impact on business success.


The Opportunity


We are seeking a Regulatory Affairs Manager to support the global registration and regulatory strategy of the company's portfolio of innovative feed additive products. This role will be responsible for preparing, coordinating, submitting, and maintaining regulatory dossiers across multiple international markets while ensuring compliance with evolving regulatory requirements. The successful candidate will work closely with R&D, Product Development, Quality, Commercial, and external regulatory authorities to support the successful commercialization of new technologies worldwide.


This is an excellent opportunity for a regulatory professional who enjoys working in a science-led environment and wants exposure to global regulatory activities within a growing international business.


Key Responsibilities


Regulatory Strategy & Product Registration


  • Support the development and execution of global regulatory strategies for existing and new products.
  • Prepare, compile, review, and submit regulatory dossiers for product registrations, renewals, amendments, and market authorizations.
  • Manage regulatory submissions across multiple regions, ensuring compliance with local and international requirements.
  • Monitor registration timelines and coordinate activities to ensure successful approvals.


Dossier Preparation & Scientific Documentation


  • Compile scientific, technical, safety, efficacy, and quality documentation required for regulatory submissions.
  • Review study reports and technical data generated through R&D and external partners.
  • Coordinate the preparation of regulatory packages in accordance with applicable feed additive regulations.
  • Maintain accurate regulatory records and submission documentation.


Regulatory Intelligence & Compliance


  • Monitor changes in global regulatory requirements impacting feed additives and animal nutrition products.
  • Assess regulatory risks and provide guidance to internal stakeholders.
  • Ensure products remain compliant with relevant legislation in target markets.
  • Support audits, inspections, and regulatory inquiries when required.


Cross-Functional Collaboration


  • Work closely with R&D, Product Development, Quality Assurance, Marketing, and Commercial teams to support product launches and lifecycl
  • e management.Provide regulatory input during new product developm
  • ent projects.Support commercial teams with regulatory-related customer inquiries and technical documentation.


Regulatory Authority & Industry Engagement


  • Build and maintain relationships with regulatory authorities, consultants, industry associations, and external partners.
  • Support responses to regulatory questions and requests for additional information.
  • Represent the company in regulatory discussions and industry working groups where appropriate.


Qualifications & Experience


Required


  • Bachelor's or Master's degree in Life Sciences, Animal Science, Veterinary Medicine, Food Science, Biotechnology, Chemistry, Regulatory Affairs, or a related discipline.
  • Experience within Regulatory Affairs, ideally involving product registrations, dossier preparation, submissions, and regulatory compliance activities.
  • Experience managing scientific and technical documentation for regulatory purposes.
  • Strong project management and organizational skills.
  • Excellent written and verbal communication skills in English.


Preferred


  • Experience within animal nutrition, feed additives, food ingredients, specialty chemicals, biotechnology, animal health, pharmaceuticals, or related regulated industries.
  • Familiarity with feed additive registration processes and global regulatory frameworks.
  • Experience interacting with regulatory authorities and external regulatory consultants.
  • Understanding of safety, efficacy, toxicology, or risk assessment data used within regulatory submissions.
  • Experience supporting international registrations across multiple regions.


What We Offer


  • Opportunity to work for a highly innovative, science-driven company developing cutting-edge animal nutrition solutions.
  • Global regulatory exposure and involvement in exciting product development projects.
  • A collaborative, agile, and entrepreneurial working environment.
  • The chance to make a visible impact within a growing international business.
  • Long-term career development opportunities within a dynamic and expanding organization.
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