Description:

Title: Regulatory Affairs Senior Associate

Duration: 5 months

Location: Remote (Newbury Park, CA)

What you will do

• 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

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

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
• Cultural awareness and sensitivity to achieve global results
• Planning and organizing abilities
• Able to prioritize and balance multiple activities
• Ability to deal with ambiguity
• Ability to influence others