BioConsortia is seeking a Director of Regulatory Affairs with excellent regulatory, scientific and business knowledge and a keen interest in bolstering the value of this innovative agricultural biotech company by securing product registrations globally. The ideal candidate will display outstanding research, analytical and communication skills and the ability to explain, clarify and simplify complex technical information. You will help build and maintain a high value registration portfolio based on our current research and innovation. You will be joining a small team with opportunities for professional development and significant intellectual contribution.
The Director of Regulatory Affairs combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. This position is responsible for planning, directing, coordinating and controlling the regulatory affairs activities related to all BioConsortia products.
Specifically, the Director of Regulatory Affairs will work with Operations & Science teams to
- Timely apply for and ensure receipt of permits to transport soils, microbes and products.
- Oversee the application process for US EPA and state registrations of products, including preparation and compilation of registration dossiers and tox testing. Develop registration strategies to expedite regulatory processes.
- Manage third party registration consultants for outside USA product registrations.
- Identify need for new regulatory policies, processes and SOPs and approve them.
- Develop and advance the organizations policy and procedures for regulatory affairs and compliance to establish a compliant culture, including on-site compliance audits.
- Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle.
- Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
- Manage Regulatory staff (it is anticipated there will be at least one and possibly two regulatory staff reporting to the Director as our portfolio grows in the coming year).
The successful candidate will possess the following background and skills:
- PhD, MS or BS degree in Microbiology, Plant Science, Genomics or related sciences (essential).
- A minimum of 5 years recent experience in agricultural product registration.
- Outstanding communication skills with the ability to explain complex information clearly and concisely.
- Strong knowledge of FIFRA regulations, guidelines, policies, standards, practices, requirements and precedents.
- Analytical thinker with strong conceptual and research skills.
- Natural leader who displays sound judgment and attention to detail.
- Ability to work under pressure and meet deadlines.
- Ability to work independently and as part of a team.
BioConsortia will consider remote work candidates residing within the USA, preferable in pacific time zone.
Authorization to work in the USA long term (US citizen or permanent resident) required.
Contact: If you have interest or want more information please contact, in complete confidence: email@example.com.