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PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.

Post : Senior Regulatory Affairs Associate (Labelling)

Job Description

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.
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 managementDefines self-development activities in order to keep current within the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association)

Candidate Profile

4+ years of experience in an industry-related environment
Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline
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

Additional Information

Experience : 4+ years

Location : Hyderabad, Bengaluru

Industry Type : Pharma/ Healthcare/ Clinical research

Functional Area : Regulatory Affairs

End Date : 30th September 2024

PAREXEL Hiring Senior Regulatory Affairs Associate