Senior Regulatory and Labeling Manager

October 12

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cauliflower • plant-based • natural products • snacks • vegan ingredients

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Description

• We are currently seeking a Sr Regulatory and Labeling Manager to join our team. • You will be responsible for overseeing all regulatory compliance and labeling activities. • You will collaborate with cross-functional teams to drive regulatory strategies and ensure product compliance with applicable regulations and standards. • The ideal candidate will have a strong background in regulatory affairs and labeling, along with excellent attention to detail and organizational skills. • Develop and implement regulatory strategies to support the timely approval and maintenance of products. • Ensure compliance with regulatory requirements and standards, including FDA, EU, and other global regulations. • Work closely with cross-functional teams to provide guidance and support on regulatory requirements and considerations. • Review and approve labeling and promotional materials to ensure compliance with regulations and standards. • Manage regulatory submissions, including the preparation and submission of regulatory filings and documentation. • Stay up-to-date with regulatory changes and industry trends to ensure compliance and mitigate risks. • Provide training and support to internal stakeholders on regulatory requirements and procedures. • Collaborate with external partners and regulatory agencies to resolve any regulatory issues or concerns. • Lead internal audits and facilitate inspections by regulatory authorities. • Participate in cross-functional projects to drive continuous improvement and ensure regulatory compliance.

Requirements

• Bachelor's degree in a scientific or related field; advanced degree preferred. • Minimum of 8 years of experience in regulatory affairs, preferably in the pharmaceutical or medical device industry. • Strong knowledge of FDA regulations, EU regulations, and other global regulatory requirements. • Experience in developing and implementing regulatory strategies. • Excellent understanding of labeling requirements and guidelines. • Proven ability to successfully manage multiple projects and deadlines. • Strong attention to detail and organizational skills. • Excellent written and verbal communication skills. • Ability to collaborate effectively with cross-functional teams. • Knowledge of quality management systems and regulatory software tools is preferred. • Regulatory certifications, such as RAC or CQA, are a plus. • Ability to adapt to a fast-paced and dynamic work environment. • Ability to travel ~60%

Benefits

• Health Care Plan (Medical, Dental & Vision) • Retirement Plan (401k, IRA) • Paid Time Off (Vacation, Sick & Public Holidays)