Senior Regulatory Affairs Associate- Labeling

4+ years

Not Disclosed

India Remote

10 July 26, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Join Us at Parexel: Uniting for a Healthier World

At Parexel, we are driven by a shared mission to improve global health. Whether through clinical trials, regulatory consulting, or market access, our work is fueled by a deep conviction in our purpose. Every role at Parexel contributes to developing therapies that ultimately benefit patients. We approach our work with empathy and a personal commitment to making a difference.

Position: Regulatory Affairs Labeling

Qualifications and Experience:

Minimum of 4 years of experience in drug development, with a focus on labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.
Strong knowledge of key labeling regulations and guidance, with hands-on experience in label development (CCDS, USPI, packaging).
Proven ability to research and create comparator labeling documents.
Experience in preparing annual reports and collaborating with Technical Operations (Tech Ops) for artwork implementation.
Proficiency in Structured Product Labeling (SPL), including all aspects, types, and troubleshooting.
Skilled in managing the review and approval of labeling within a document management system.
Familiarity with electronic document management systems and experience in electronic submissions.
Expertise in Life Cycle Management, including post-approval labeling submissions and PSUR submissions.

At Parexel, our values align with our mission, driving us to achieve great things together. If you share our passion and commitment to making a difference in healthcare, we invite you to join our team.

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Senior Regulatory Affairs Associate- Labeling

Job Description

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