Regulatory Affairs Specialist (Clinical)

SPECTRAFORCE; United States; Remote; USD 74,000 - 120,000; Full time

Job summary

A leading company is seeking a Regulatory Affairs Specialist (Clinical) to support complex projects and regulatory documentation. The ideal candidate will have a Bachelor's and Master's Degree in Life Sciences, alongside 3-4 years of experience in regulatory affairs. This remote contract position offers an annual salary reflecting industry standards, with responsibilities including team leadership and client presentations.

Qualifications

• 3-4 years of relevant experience is required.
• Strong understanding of R&D processes and regulations.
• Proficient in communication, relationship management, and decision-making.

Responsibilities

• Act as a Regulatory Team Leader and prepare regulatory documentation.
• Establish relationships and present on regulatory issues.
• Provide guidance and training to junior colleagues.

Skills

Strong communication

Organizational skills

Ability to manage multiple projects

Decision-making ability

Education

Bachelor's Degree in Life sciences

Master's Degree in Life sciences

Tools

Microsoft Office

Publishing tools

Job description

Regulatory Affairs Specialist (Clinical)

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Job title: Regulatory Affairs Specialist (Clinical)

Location: Remote

Duration: 6 months

This position's starting pay is: $37/hr.

Individual contributor who is fully proficient in applying subject matter knowledge for a professional discipline. Works under limited supervision.

Essential Functions

• Acts as a Regulatory Team Leader on more complex projects, which may include technical writing;
• Prepares and/or reviews regulatory documentation in area of expertise, as appropriate;
• Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments;
• Acts as an SME/expert in Regulatory knowledge in Chemistry, Manufacturing and Controls/Lifecycle Maintenance/Marketing Authorization Transfers/Labeling/Publishing as applicable;
• Understands the Scope of Work, deliverables, and manages budget for projects, managing workload accordingly;
• May provide guidance to junior colleagues, including feedback on technical documents, and assist in their training and development;
• May present to clients on complex regulatory processes at large meetings via phone or in person;
• May review regulatory standard operating procedures as assigned;
• May prepare and deliver regulatory training to small groups or individuals;
• Performs other tasks or assignments, as delegated by Regulatory management.

Qualifications

• Bachelor's Degree in Life sciences or related discipline (Req)
• Master's Degree in Life sciences or related discipline (Req)
• At least 3-4 years relevant experience
• Good understanding of the R&D process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws, and guidelines
• Possesses specific regulatory or technical expertise
• Strong communication and organizational skills
• Ability to establish and maintain effective relationships with coworkers, managers, and clients
• Proficient in Microsoft Office and publishing tools
• Self-motivated and enthusiastic
• Ability to manage multiple projects with guidance from senior staff
• Ability to follow SOPs and suggest process improvements
• Decision-making ability on discrete tasks under supervision
• Advanced knowledge within a specific discipline gained through experience or education
• Ability to adapt quickly to changing environments

For information on benefits, equal opportunity employment, and location-specific notices, click here.

SPECTRAFORCE is committed to fair compensation and wage transparency in accordance with applicable laws.

Additional Details

• Seniority level: Associate
• Employment type: Contract
• Job function: Writing/Editing

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