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
