Regulatory Affairs Senior Associate #26-18344

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.

IND01