Vice President of Scientific and Regulatory Affairs
Functional Foods
The Vice President of Scientific and Regulatory Affairs will lead the scientific and regulatory team responsible for supporting product development, QA/QC and regulatory compliance. Introduces new products and processes into company strategy and makes recommendations for the improvement and cost reduction of existing products and processes through R&D. Manages the Quality Department, in house Lab and regulatory review. Must be familiar with and knowledgeable of lab sciences, cGMPs, SOPs, and Dietary Supplement FDA Regulations and facility controls.
Essential Functions:
- Oversee the QA/QC lab and regulatory team.
- Assist in product development and R&D functions, including internal and external providers.
- Manage regulatory compliance of both products and facility to meet FDA standards.
- Oversee analytical testing including physical and chemical tests to support routine Quality Control testing for bulk finished capsules.
- Perform out of specification investigations, and develops controls for out of specification reports.
- Lead efforts in failure investigations and in SOP development.
- Design and support validation procedures of raw materials, stability and external suppliers.
- Oversee regulatory compliance for product substantiation, facility controls and SOP’s.
- Manage NSF and other facility audits.
- Assures maintenance of research records and documents pertaining to formulations and products.
- Ensures that executives and managers are advised of developments in research and development department.
- Facilitates communication and cooperation among suppliers.
- Contributes to new product meetings as needed.
- Oversees laboratory functions and operation.
- Oversees Quality Department functions and operation
- Conducts regular meetings with Scientific Affairs to communicate administrative policy and to coordinate divisional activities.
- Oversees regulatory review of printed material.
- Update Enzyme Research Group website.
- Oversees research studies.
- Processes International paperwork for product submissions.
- Takes the lead in coordinating recalls.
- Responsible for maintaining traceability for products and for conducting root cause analyses for incidents.
- Work with the Scientific Advisory Board as needed.
- Work with the educational department to establish accuracy.
- Write articles, answer interview questions on behalf of company.
- Improve existing products.
- Keep up to date with enzyme therapy, delivery systems and trends.
- Assist Operating Chairman with projects as needed.
Knowledge and Skill Requirements:
- Ability to troubleshoot analytical issues and equipment
- Ability to follow written and verbal directions with high degree of accuracy
- Demonstrated leadership experience both in managing and working in a laboratory
- Fluency with following applications: Excel, Word and PowerPoint
- Candidate must be reliable, dependable and able to work independently
- Ability to understand and comprehend instructions in English
- Excellent written and verbal communication skills
- Skilled at analyzing data and summarizing results
- Problem solving skills
- Good organizational and follow up skills
- High degree of attention to detail
- Natural ability to work in a team oriented environment
- Ability to perform presentations to both company staff and external customers
- Proven self-starter and highly motivated
- Knowledge and experience with enzyme supplements
- Knowledge of Food Chemical Codex (FCC) routine enzyme assays
- Keep up to date with NSF, FDA and FTC standards on Dietary Supplements
- Able to communicate effectively with government officials and organizations
Education and Experience:
- PhD Degree in Chemistry and/or Lab Sciences is required
- Education in nutrition and enzyme therapy
- Quality Assurance experience
- Experience in writing
