Senior Regulatory Affairs Associate

Key Accountabilities:

Project Execution:

Regulatory Affairs Labeling 

• Must have  4+ years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality. 
• Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging) 
• The ability to research and create comparator labeling documents. 
• Strong understanding and experience creating annual reports. 
• The ability to collaborate with Tech Ops for artwork implementation. 
• Proficiency in SPL (all aspects, types, and troubleshooting) and the ability to manage the review and approval of labeling in a document management system. 
• Electronic document management systems use and / or electronic submission experience. 
• Life Cycle Management, Post Approval Labeling submissions including PSUR submissions. 

PAREXEL-related Activities:

• Meets established metrics as specified in scorecard on an annual basis
• Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, training compliance, project deliverable archiving, participation in internal initiatives/projects as requested by management
• Defines self-development activities in order to keep current within the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association)

Skills:

• Project management knowledge
• Client-focused approach to work
• Results orientation
• Teamwork and collaboration skills
• Excellent interpersonal and intercultural communication skills, both written and verbal
• Critical thinking and problem-solving skills
• Proficiency in local language and extensive working knowledge of the English language

Business Development:

• Continue to build a network of industry colleagues through relationships formed during project engagements or through other industry experience
• Communicates potential new business leads to PC management and account managers
• May participate in project scoping calls and/or proposal preparation with the support of senior colleagues

Knowledge and Experience:

• 4+ years of experience in an industry-related environment

Education:

• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline