Regulatory Manager

Apex Life Sciences Berkeley, CA

POSITION SUMMARY

The Quality and Regulatory team is responsible for overseeing safety and quality standards, as well as compliance with food and supplements relations. The Regulatory Compliance Manager reports to the Director of Quality Assurance & Regulatory Compliance and is responsible for Regulatory oversight and all documentation associated with our full line of sports nutrition products.

RESPONSIBILITIES


• Partners with Director of Quality Assurance & Regulatory Compliance to ensure compliance of all products in an ever-changing Regulatory environment


• Researches and interprets relations to ide policies and programs relating to ingredients, products, supply chain, and manufacturing facilities


• Establishes set standards and specifications for processes and products as it relates to quality and safety parameters


• Manages Regulatory approval process including but not limited:

o Raw Materials

o Finished Products

o Vendors (both raw material suppliers, 3rd party labs, and contract manufacturers)


• Reviews and approves labels for all new and/or updated products as well as product messaging relating to usage instructions, nutrition information and product claims


• Understands key ingredients and how they are related both independently and when combined in products; provides analysis, interpretation, and recommendations accordingly


• Represents and its interests to Regulatory bodies and customers


• Performs internal audits on current practices to ensure compliance is maintained, gaps are identified, and continuous improvements are made


• Ensures success, timely completion, and cost containment of Regulatory projects (which may involve consultants)


• Manages international product licensing needs and provide guidance on international Regulatory requirements for products


• Responds to routine customer inquiries and follows up promptly


• Manages change requests from cross functional teams and ensures proper documentation is maintained throughout the process


• Liaises with R&D, Marketing, and Production to understand business needs and deliverables and collaborates to provide recommendations during product commercialization process; enables sound decision making with regard to compliance with labels, claims and specifications


• Responsible for the dissemination of critical Regulatory information throughout the company through training, updates, etc.


• Participates in symposia, industry and governmental groups and conferences


• Other duties as required or assigned

SKILLS/QUALIFICATIONS


• BS/BA degree required; Food Science or similar major preferred


• 3+ years of regulatory experience in the food or supplement industry


• Expertise in US regulatory requirements required


• Knowledge of or experience with the following is not required but preferred...

o foreign relation requirements

o HACCP, FSMA, 21 CFR Part 110/111/101/117, Kosher, and other Regulatory issues

o structure-function and front of package claims

o organic certification

o experience with internal/third party audits (NSF, AIB, etc.)


• Must be detail oriented


• Excellent written and verbal communication skills with proven ability to influence (communicates professionally and effectively with a diverse population, builds credibility, and inspires trust)


• Well organized with excellent judgment and strong creative problem-solving skills


• Quick analytical thinker; comfortable with change


• Effective decision maker with ability to work well under pressure


• Excellent customer service


• Ability and willingness to work hands-on as needed


• Occasional time with employees in the plant during morning or evening shifts required


• Additional skills and competencies for success in this role:

1. Intellectual horsepower

2. Critical thinking

3. Strategic agility

4. Accountability

5. Managerial courage

6. Time awareness

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [Click Here to Email Your Resumé] or 844-463-6178.