Job description

Duration: 05 months contract

Description:

In this vital role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization.
To coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead in compliance with corporate standards and regulatory requirements.
To manage and execute the preparation, delivery, and electronic archiving of documentation for inclusion in US regulatory submissions
To assist the Global Regulatory Lead to manage GRT interactions

Top Must Have Skill Sets:

Strong communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Planning and organizing abilities
Prior regulatory knowledge experience as a clinical strategist (Preferred)
FDA experience is a bonus

Key responsibilities include:

Assist US Regulatory Lead to support local regulatory activities (e.g. IND submissions and agency meetings)
Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with US Regulatory Lead
Appropriately archive regulatory documents and agency communications
Collaborate with CRO’s / partners to support site initiation
Complete regulatory forms to support agency communications
Participate in GRT to support execution of regulatory strategy
Coordinate QC of regulatory documentation (e.g. briefing materials)
Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
Assist in template development and maintenance
Respond to specific requests from and communicate relevant issues to GRT
Actively support regulatory compliance

Basic Qualifications:

Master’s degree
Bachelor’s degree and 2 years of Regulatory Affairs experience
Associate’s degree and 6 years of Regulatory Affairs experience
High school diploma / GED and 8 years of Regulatory Affairs experience

Preferred Qualifications:

Strong communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to collaborate with team members to tackle problems and develop a course of action
Planning and organizing abilities
Able to prioritize and balance multiple activities

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.

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Regulatory Affairs Senior Associate #26-18344

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