Regulatory Affairs Manager

Aleph Farms is a leading company in the field of cultivated meat.

We grow beef steaks, from non-genetically engineered and non-immortalized cells isolated from a living cow, without slaughtering the animal and with a significantly reduced impact to the environment.

The company’s vision is to provide unconditional quality nutrition for anyone, anytime, anywhere.

RESPONSIBILITIES

Responsible for all regulatory activities, including:

  • Developing a submission strategy according to regulatory requirements in all regions, including required studies and study design
  • Performing and documenting regulatory assessments of life-cycle changes according to regulatory requirements
  • Reviewing of all study reports, scientific justifications and additional submission documentation
  • Identifying and communicating regulatory risks and mitigations
  • Compiling submission package
  • Responding to information requests from global Health Authorities
  • Exploring submission pathways and regulatory opportunities, and recommending the most appropriate route
  • Utilizes strategic regulatory thinking along with technical expertise to implement regulatory strategies
  • Provides regulatory guidance to project team members regarding health authority requirements for validation and submission
  • Coordinates all activities concerned with the strategy, submission, and approval of products to government regulatory agencies between internal and external functions
  • Coordinate project submission timelines in multiple regions
  • Escalates issues to Regulatory Affairs Management that affect registration, regulatory compliance and continued lifecycle management of the product
  • Identifies and implements improvements to regulatory processes and procedures
  • Review and provide regulatory assessment for changes in approved products
  • Prepare and submit required regulatory applications for new products and maintenance of existing products with limited supervision

The Details

Rehovot
Management
Full-time

About the Company

Aleph Farms

Cultivated steak for earth and space.

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