Senior Regulatory Affairs Associate (Labelling)
Bengaluru, Karnataka, India 求人ID R0000025181 Category Regulatory / ConsultingAbout this Role
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
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