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Regulatory Submissions Coordinator III

2 months ago

Skaneateles Falls, New York, United States Adecco US, Inc. Full time

Adecco US, Inc. is currently seeking a qualified candidate for the position of Regulatory Affairs Associate III. This role can be performed either fully remotely or in a hybrid setting.

Work Schedule: 40 hours per week

Compensation: The hourly wage for this position is $70. Compensation may vary based on experience, education, geographic location, and other relevant factors.

Key Responsibilities:

  • Coordinate and prepare documentation for regulatory submissions.
  • Review and assess technical and scientific data necessary for product submissions.
  • Monitor the status and progress of regulatory documentation.
  • Edit and proofread regulatory documents to ensure accuracy.
  • Assist in the preparation and review of labeling, standard operating procedures (SOPs), and other departmental documents.
  • Compile regulatory documents for submission under supervision.
  • Contribute as an active member of project teams as needed.
  • Prepare responses to inquiries from regulatory authorities.
  • Maintain regulatory files in compliance with established requirements.
  • Stay informed about current regulatory requirements.
  • May oversee a specific product portfolio within the region.

Qualifications:

  • Bachelor's degree or equivalent in pharmacy or a related scientific field.
  • 0-2 years of regulatory experience, preferably in a healthcare setting.
  • Ability to manage multiple projects from a regulatory perspective.
  • Strong multitasking and prioritization skills.

Benefits: Our benefits package includes medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an Employee Assistance Program (EAP), commuter benefits, and a 401K plan. Employees have the flexibility to select coverage that meets their individual needs. Paid leave options may include Sick Leave and other paid leave as required by law, along with holiday pay based on eligibility.

Equal Opportunity Employer: Adecco US, Inc. is an Equal Opportunity Employer, including veterans and individuals with disabilities.

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