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Regulatory & Labeling Specialist

Katalyst HealthCares & Life Sciences
Charlotte, NC
Full-time

Responsibilities :

Provide support for the review and approval of New Product Development (NPD) projects regarding market and regulatory health authority requirements.

Assist in the drafting and maintenance of product dossiers, market authorizations, and regulatory submissions for Suave and ChapStick.

Respond to health authority, licensing agents, and retailer requests for regulatory documentation.

Stay up to date with regulatory changes and requirements, ensuring that Client's processes and procedures are aligned. Support with the implementation of requirements from new or changed Global, Federal and State regulations.

Provide general regulatory support for investigations and projects.

Deliver regulatory support for labeling and artwork projects, including MSA exit.

Act as a reviewer and approver of labeling documents to ensure highly complaint artwork and labeling.

Collaborate closely with cross-functional teams, including Regulatory, R&D and Marketing, to ensure smooth and timely execution of labeling activities.

Requirements :

Bachelor's degree in a related field (, Life Sciences, Chemistry, or a related discipline).

Minimum of years of experience in a regulatory or regulatory labeling role within the personal care or consumer goods industry.

Knowledge of regulatory requirements for cosmetics and OTC drug products, including FDA and MoCRA regulations.

Strong analytical and problem-solving skills, with the ability to conduct root cause analysis effectively.

Excellent communication skills, both written and verbal.

Detail-oriented with the ability to manage and prioritize multiple tasks.

Experience with complaint management and corrective actions implementation.

Positive and energetic individual with a strong business acumen, an abiding sense of urgency to achieve results.

Consumer-centric, creative, and design-oriented.

Inquisitive individual who has a history of seeking out best practices and successfully assimilating them into their organization.

Invokes trust, collaboration, shared accountability, and continuous improvement with the ability to quickly develop trust and loyalty at all levels in the organization and with external partners.

Knows what excellence looks like and how to get there.

Ability to develop and implement strategy, with a high bias for execution and activation, comfort with getting hands dirty.

Demonstrated track record of problem solving and priority setting.

30+ days ago
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