This position is responsible for developing and implementing corporate regulatory requirements to ensure Food Safety/Regulatory compliance with all business-related laws, regulations, programs, certifications, ad credentials. The Regulatory Compliance Manager will support regulations, standards and policies issued by relevant regulatory authorities to apply them in business practices and assess risks as well as emerging issues.
The Corporate Regulatory Manager will serve as a key resource and authority on compliance to various functions by providing regulatory input, programs, and guidance to ensure proper compliance foundations, records, and product commercialization initiatives. They will also be responsible for developing and sustaining training on Food Safety Compliance Regulations on behalf of the company.
RESPONSIBILITIES / DUTIES:
- Develop new regulatory policies, processes and SOPs and provide training and guidance at all levels of the organization to ensure a robust corporate compliance program.
- Enforce adherence to the program by managing and maintaining regulatory requirements and point of contact for regulatory responsibilities for business, functions, importations, and vendors.
- Assist cross-functional areas with internal and external compliance initiatives including audits and site inspections by Federal, State, and International regulatory agencies. As needed, track filing submission dates, responses, and approval dates to ensure compliance.
- Support Operational teams by managing supplier and vendor programs and facilitating approval processes. Prepare, collect, or coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners.
- Support Procurement, Supply Chain Operations, Innovation, Marketing, Sales teams with regulatory related aspects of the business to follow both US and international regulatory requirements.
- Provide support to international departments with FDA/USDA compliance on Imports and Exports.
- Respond to routine customer inquiries, investigate, and respond to customer complaints from food safety/regulatory perspective.
- Review product labeling, advertising, and marketing material for appropriateness and compliance to regulatory requirements and laws.
- Perform regulatory assessment of new and changed products.
- Perform assessments and/or mock audits for manufacturing plants.
- Compiling and maintaining claim files for products.
- Provide regulatory support to existing and new cross-functional product core teams and serve as the regulatory core team lead.
- Participate project activities and review key project documents such as product design protocols related to verification and validation, risk assessment, etc.
- Facilitate preparation of US registrations and communicate in other regions (outside the US) to ensure registration documents are provided.
- Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
WORK EXPERIENCE / KNOWLEDGE:
- 7+ years of management experience working in a leadership role in the food industry.
- Minimum of 4 years within a technical environment; Regulatory Affairs, Quality Assurance or Safety.
- 3+ years of management experience in international regulatory compliance (MX/USA).
- Excellent knowledge of relevant Federal and State compliance regulations, FSMA requirements, GMPs, SQF & FSVP auditing processes, food and labeling regulations related to Dairy.
- Experience managing ReposiTrak platform.
- Demonstrated experience developing compliance programs and implementing regulatory strategies and protocols.
- Able to identify and assess business risks throughout the company.
- Able to interface with Regulatory agencies.
- Strong ability to negotiate and communicate effectively at multiple levels, including Regulatory authorities, superiors, peers, employees, customers, and other groups in the organization.
SKILLS / OTHER PERSONAL ATTRIBUTES REQUIRED:
- Bilingual Preferred
- Strong organizational, writing and reviewing skills.
- Excellent interpersonal skills and ability to work collaboratively.
- Capable of managing simultaneously workloads, multiple customers demands and shifting priorities within a fast-paced, rapidly evolving environment.
- Strong attention to detail and ability to multitask and handle increasing levels of responsibilities.
- Ability to operate independently and proactively.
- Qualified candidates will possess at least a Bachelor of Arts or Science in a science field from a 4-year accredited university or college.
- Must be available during core business hours, additional needs may vary depending on the project or assignment.
- Performs external vendor/co-packer on-site audits.
- Normal office environment with little exposure to noise, dust and temperatures.
- The ability to lift, carry or otherwise move objects of up to 10 pounds is necessary.
- Must be open to travel 10 – 20% of time.