197 applicants

Company

Rho · 2 days ago

Regulatory Operations Specialist I or II

United States

Full-time

Remote

Mid Level

$70K/yr - $90K/yr

3+ years exp

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Responsibilities

Collaborates with sponsors and internal team members in the preparation, assembly, submission, and maintenance of regulatory submissions in compliance with applicable regulations and sponsor specifications

Collaborates with sponsors and internal team members to avoid and address validation and technical specifications

Publishes regulatory documents in accordance with eCTD standards and regulatory agency specifications

As needed, assists with the formatting and quality control of a variety of regulatory documents.

Supports day-to-day operations activities

Assists with assigned project activities

Attends internal training sessions for growth and development

Exhibit Rho’s Core Values at all times

Work in accordance with Rho’s Remote Hybrid Work Policy and attend meetings at any of Rho’s offices, sponsor site or client’s office as needed

Provide excellent customer service to internal and external clients in a timely and professional manner

Respond to email and other communication requests in a timely fashion using a variety of methods including but not limited to email, instant messaging and other communication tools

Ability to maintain confidentiality

Takes initiative to complete project-specific responsibilities with minimal supervision

Other duties as assigned

Qualification

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CRO experienceECTD publishing toolsReport level publishingRegulatory operations activitiesMS WordExcelAdobe AcrobatLife Sciences knowledgeSharePoint knowledge

Required

Bachelor’s degree in related field

Minimum 3 years of prior experience

3 years of industry experience (in CRO or Pharmaceuticals)

Experience with eCTD publishing tools

Ability to perform report level publishing and submission publishing independently

Advanced MS Word, Excel, and Adobe Acrobat (including applicable electronic publishing plug-ins)

Must be able to communicate effectively, positively, and professionally with internal and external clients, both written and verbal

Strong organizational skills, including the ability to multi-task and balance individual and team responsibilities

Preferred

Experience in Life Sciences is preferred but not required, particularly familiarity with research processes and terminology

Experience with eCTD publishing and document preparation as well as regulatory operations activities such as editorial quality review in general is a plus

Knowledge of SharePoint is preferred