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Regulatory Specialist

Company: Denken Solutions Inc
Location: Holbrook
Posted on: May 25, 2023

Job Description:

* The Regulatory Specialist plays a critical role in ensuring in-market regulatory compliance of product packaging and provides other administrative support to the U.S. Regulatory & Scientific Affairs department, Client Health Science U.S.

* Specific responsibilities include developing and reviewing product label content and packaging artwork, data entry into internal and external databases (e.g., Supplement OWL), document preparation, and general administrative support as needed. Additional projects may include compiling and organizing department information and preparing summaries for reference by the team. The Regulatory Specialist will primarily focus on implementing label updates quickly and accurately while ensuring completeness and compliance.

* A high level of support and supervision will be provided ensuring individual and company success.

* This role requires a strong work ethic, attention to detail, organization, and capability to juggle multiple obligations simultaneously, while still delivering at extremely high standards and with a sense of urgency.


*Key Responsibilities:*


* Review product label content and implement required updates.

* Review packaging artwork to ensure updates have been implemented accurately and the labeling is fully compliant.

* Coordinate approvals. Route internal documents through relevant workflow systems to obtain cross-functional feedback and approvals.

* Data Entry. Carefully input key data into internal and external databases as directed to provide accurate product information to our systems and consumers.

* Ad hoc administrative support for Regulatory, Scientific & Medical Affairs team which may include document preparation, coordination of document edits, or other administrative duties as assigned.


*Experience and Education Requirements:*


Job Type: Contract


Salary: $20.00 - $25.00 per hour


Schedule:

* Monday to Friday




Ability to commute/relocate:

* Holbrook, NY 11741: Reliably commute or planning to relocate before starting work (Required)


Experience:

* FDA regulations: 1 year (Required)



Work Location: One location

Keywords: Denken Solutions Inc, Westport , Regulatory Specialist, Other , Holbrook, Connecticut

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