Regulatory & Labeling Specialist

3 weeks ago


Charlotte, North Carolina, United States Katalyst HealthCares & Life Sciences Full time
Job Title: Regulatory & Labeling Specialist

At Katalyst HealthCares & Life Sciences, we are seeking a highly skilled Regulatory & Labeling Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for cosmetics and OTC drug products.

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 compliant 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.


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