Regulatory Affairs Director for Custom Juice and Flavor Blends
3 weeks ago
American Fruits & Flavors is a leading manufacturer of custom juice and flavor blends for industrial users worldwide. With over 50 years of experience, we have established ourselves as a trusted partner for innovative ingredient blends and flavor systems.
About the RoleWe are seeking an experienced Regulatory Affairs Supervisor to join our team in Southern California. The successful candidate will be responsible for ensuring compliance with regulatory agency requirements and providing internal regulatory support and guidance to staff. As a key member of our Regulatory Department, you will play a vital role in maintaining company-wide compliance and ensuring the integrity of our raw material substantiation database.
Responsibilities- Provide internal regulatory support and compliance guidance regarding AFF products and intended end use.
- Evaluate and provide interpretation or guidance to staff on next steps when supplier documentation is not complete or clear.
- Maintain integrity of AFF raw material substantiation database in FABS (review, interpret, validate information entered in AFF database).
- Review regulatory and technical documents from suppliers for compliance with AFF company requirements as part of supplier approval process.
- Review regulations and supplier documents to determine International Compliance for raw materials. Maintain this information in the AFF compliance database.
- Verification of International compliance data entered by RA Specialists to ensure integrity of the AFF database.
- Review AFF formulas & technical data for compliance with applicable regulations, customer requirements and industry guidelines
- Generate draft documents to support AFF ingredient registration for import to various foreign countries. (For manager review.)
- Generate draft documents and responses to customs agent's requests for information related to AFF products. (For manager review.)
- Communicate approved information to customers, certification agencies, customs or regulatory agencies, along company guidelines.
- Liaise with appropriate individuals within AFF regulatory, EHS, and quality for information exchange and proactive handling of product safety/regulatory issues. Ensure proper understanding in both directions.
- Approve initial AFF product label profile.
- Manage the process of foreign language label creation and approval.
- Submit AFF products for Kosher, Halal, and organic certification.
- Participate in Organic and Halal audits.
- Review and approve FIDS generated by the department staff. Act as backup to generate FIDS.
- TTB filing of AFF formulas.
- Complete customer documents/questionnaires related to certification of their products that utilize AFF ingredients.
- Review and approve SDS and provide creation guidance for staff.
- Participate in conversion of R&D to active products and perform regulatory review of formulas during that process. Apply for certs when needed.
- Interpret regulations; research, develop, implement, and review technical data for compliance.
- Advise AFF personnel regarding new governmental regulatory developments.
- Maintain current knowledge of, and assure compliance with, existing and emerging regulations, standards and guidance documents as related to TTB, IFRA, Kosher, Halal, and Organic.
- Responsible for reading, comprehending, and applying subject matter expertise to product labeling, food allergens, genetically modified foods, bioengineering, nutrition, organic and religious suitability, FEMA GRAS, FDA, USDA, Prop 65 and international laws affecting flavor and juice as ingredients for use in further manufacturing.
- Bulk labeling of AFF products in compliance with applicable country regulation.
- Complete formal written response to customer inquiries related to regulatory affairs and product certifications.
- Ensure appropriate customs duty classifications are determined and applied.
- Bachelor's or Master's degree in Chemistry, Chemical Engineering, Food Science or similar field of study.
- Minimum 3-5 years of relevant regulatory and supervisory experience.
- Experience with Halal, Kosher or Organic certification process.
- Experience with International Regulations preferred.
- Ability to apply global regulatory authorities' regulations and/or guidance.
- Familiarity with TTB regulations.
- Ability to read, analyze and interpret professional journals, technical procedures, scientific data, governmental regulations, and chemical hazard information and safety procedures.
- Ability to interpret and prepare reports.
- Adept at using logic and reasoning to identify solutions to problems.
- Ability to apply mathematical and statistical concepts to achieve desired results.
- Excellent attention to accuracy and detail.
- Strong verbal and written communication skills (including analysis, interpretation, & reasoning).
- Ability to handle multiple projects simultaneously, prioritizing work to meet multiple deadlines.
- High degree of proficiency MS Office Suite, Outlook & Internet applications and ERP Systems
-
Regulatory Affairs Expert
1 day ago
San Fernando, California, United States AppleOne Employment Services Full timeWe are seeking a skilled Regulatory Affairs Specialist to join our team at AppleOne Employment Services. In this role, you will be responsible for supervising and supporting the Regulatory Department, ensuring compliance with existing and emerging regulations, standards, guidance documents, and international laws. This includes TTB, IFRA, Kosher, halal,...
-
Quality and Regulatory Affairs Director
7 days ago
San Francisco, California, United States Michael Page Full timeAbout the RoleWe are seeking an experienced Quality and Regulatory Affairs Director to join our client, a leading beverage manufacturing company. This is an exciting opportunity for a professional with a strong background in quality assurance and regulatory compliance.Key ResponsibilitiesLead the quality assurance and regulatory affairs team to ensure...
-
Regulatory Affairs Director
6 days ago
San Francisco, California, United States 10 Fitness Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Director to join our team at 10 Fitness. As a key member of our management team, you will be responsible for ensuring compliance with all relevant laws and regulations in the fitness industry.ResponsibilitiesDevelop and implement effective regulatory strategies to ensure compliance with...
-
Regulatory Affairs Leadership Position
2 weeks ago
San Fernando, California, United States AppleOne Full timeJob OverviewWe are seeking a highly skilled Regulatory Affairs Supervisor to join our team at AppleOne. This is a unique opportunity to work with a leading workforce management company that is committed to excellence in Human Resources and Strategic, Inclusive Procurement.
-
Regulatory Affairs Director
3 weeks ago
San Diego, California, United States Dennis Partners Full timeCompany OverviewThe clinical-stage biotech company, Dennis Partners, is a dynamic organization focused on developing innovative small molecule therapeutics for the treatment of devastating cancers and immune disorders. With multiple programs in clinical trials and a rapidly growing clinical portfolio, this is an exciting time to join our team as a Vice...
-
San Francisco, California, United States Stirling Q&R Full timeJob Title: Regulatory Affairs Director for Pharmaceutical Product DevelopmentAbout Stirling Q&R:We are a leading pharmaceutical company in the San Francisco Bay Area, committed to developing and commercializing innovative therapeutic products. Our dynamic environment offers excellent opportunities for growth and professional development.Job Description:This...
-
Global Regulatory Affairs Leader
3 weeks ago
San Francisco, California, United States Daiichi Sankyo, Inc. Full timeAbout Daiichi SankyoDaiichi Sankyo Group is a pharmaceutical leader with over 125 years of scientific expertise and a presence in more than 20 countries. We are dedicated to creating innovative therapies that improve standards of care for patients globally.Our company's vision is to become a global pharma innovator with a competitive advantage in oncology,...
-
Regulatory Affairs Director
6 days ago
San Francisco, California, United States Daiichi Sankyo, Inc. Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Director to lead our US strategy for pharmaceutical development.Job DescriptionThis is an exciting opportunity to work with a cutting-edge asset by effectively liaising, negotiating and partnering with FDA. You will create and implement effective regulatory strategies to deliver on efficient...
-
Regulatory Affairs Leader
1 week ago
San Diego, California, United States Lifelancer Full timeAt Lifelancer, we connect talent with opportunities in life sciences, pharma, and IT. Our platform helps professionals grow their careers in a variety of domains.We are seeking an experienced Regulatory Affairs professional to join our team as a Senior Manager. This role will play a crucial part in supporting regulatory needs across the business, from...
-
Regulatory Affairs Director
3 weeks ago
San Francisco, California, United States Daiichi Sankyo, Inc. Full timeAbout Daiichi Sankyo, Inc.">Daiichi Sankyo Group is a global pharmaceutical innovator dedicated to improving standards of care and addressing diverse unmet medical needs worldwide. With over 100 years of scientific expertise and a presence in more than 20 countries, the company has a robust pipeline of promising new medicines.">Our Vision">Under our 2025...
-
San Francisco, California, United States Daiichi Sankyo, Inc. Full timeAbout Daiichi SankyoDaiichi Sankyo Group is a global pharmaceutical innovator with a rich legacy of innovation. With over 125 years of scientific expertise and a presence in more than 20 countries, the company is dedicated to creating and supplying innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs...
-
Regulatory Affairs Expert
4 weeks ago
San Jose, California, United States San Jose Water Company Full timeAbout San Jose Water CompanySan Jose Water Company, a leading water utility in Silicon Valley, is seeking a highly skilled Regulatory Affairs Analyst to join our team. With over 150 years of experience, we pride ourselves on providing high-quality, life-sustaining water to over 1 million people.Compensation and BenefitsWe offer a competitive annual salary of...
-
Regulatory Affairs Specialist
1 week ago
San Diego, California, United States CorDx Full timeCorDx is a leading biotech organization pushing the boundaries of innovation and supply in global health. With over 2,100 employees worldwide, serving millions of users across 100 countries, we deliver rapid testing and point-of-care medical device solutions for infectious diseases like COVID-19, pregnancy, and more.We are at the forefront of technology,...
-
Regulatory Affairs Expert
3 weeks ago
San Diego, California, United States Lifelancer Full timeOverviewCrinetics Pharmaceuticals is a pioneering biotech company dedicated to developing innovative therapies for endocrine diseases and tumors. Our mission is to transform lives through rigorous innovation, patient-centric culture, and a team-oriented approach.We are seeking a highly skilled Manager, Regulatory Affairs to join our team in San Diego, CA....
-
Regulatory Affairs CMC Specialist
3 weeks ago
San Mateo, California, United States Fladger Assoc. Inc. Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs CMC Associate to join our team at Fladger Assoc. Inc. in Foster City, CA. This is an exciting opportunity for a professional with a strong background in regulatory affairs and experience in supporting biologic and small molecule drugs.About the RoleThe successful candidate will provide regulatory...
-
Regulatory Affairs Professional
3 weeks ago
San Diego, California, United States Cypress HCM Full timeAbout Cypress HCMCypress HCM is a leading company in the medical device industry, dedicated to providing innovative solutions for regulatory affairs and product development.
-
Customer Service Ambassador
3 weeks ago
San Diego, California, United States Robeks Juice Full timeWe are seeking a Customer Service Ambassador to join our team at Robeks Juice. As a key member of our staff, you will be responsible for delivering exceptional customer service and creating a welcoming atmosphere for our guests.Key Responsibilities:Smile and maintain eye contact with guestsMake connections with guests and provide personalized serviceWork a...
-
South San Francisco, California, United States AbbVie Full timeCompany OverviewA leader in oncology research and development, AbbVie is committed to discovering and delivering innovative treatments for various types of cancer. Our team works tirelessly to combine expertise in immuno-oncology, stem cells, and cell-signaling with knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor...
-
Regulatory Affairs CMC Specialist
3 weeks ago
San Mateo, California, United States Fladger Assoc. Inc. Full timeFladger Assoc. Inc. is seeking a highly skilled Regulatory Affairs CMC Associate to join our team in Foster City, CA.About the RoleThis exciting opportunity offers a competitive salary of approximately $120,000 - $180,000 per year, commensurate with experience, plus benefits.Key ResponsibilitiesProvide Regulatory CMC support for biologic and small molecule...
-
Regulatory Affairs Expert
3 weeks ago
San Francisco, California, United States Daiichi Sankyo, Inc. Full timeKey Responsibilities:As a Regulatory Affairs Expert at Daiichi Sankyo, you will play a critical role in ensuring the compliance of our products with global regulations and guidelines. This includes managing the development and maintenance of Company Core Data Sheets (CCDS) for assigned products, as well as driving the maintenance of global labeling and...
