Senior Regulatory Affairs Associate- Labeling

3-5 years

Preferred by Comapny

India

10 Nov. 25, 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, CPC Certified, 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

Job Title: Labeling and Packaging Regulatory Affairs Specialist

Job Description:

We are seeking a Labeling and Packaging Regulatory Affairs Specialist with a minimum of 4+ years of experiencein drug development, focusing on labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality. The ideal candidate will have a deep understanding of regulatory requirements and a proven track record in label development and packaging compliance.

Key Responsibilities:

Labeling Regulations & Development:
- Extensive experience with labeling regulations and guidance (e.g., CCDS, USPI).
- Lead and support the development of labeling documents, ensuring compliance with relevant regulations.
- Research and create comparator labeling documents for submissions.
Annual Reports & Label Updates:
- Strong understanding and experience in creating annual reports for labeling purposes.
- Handle post-approval labeling submissions including PSUR (Periodic Safety Update Report)submissions.
Artwork Implementation & Coordination:
- Collaborate with Tech Operations to ensure effective artwork implementation and alignment with labeling requirements.
- Coordinate the approval process for printed packaging components to meet design and legislative requirements.
- Manage and track artwork changes and ensure all components meet the required guidelines and standards.
Document Management Systems:
- Proficient in SPL (Structured Product Labeling), including all aspects, types, and troubleshooting of SPL submissions.
- Experience in using electronic document management systems and handling electronic submissions.
Lifecycle Management & Post-Approval:
- Ensure proper lifecycle management of labeling materials, including managing safety variations, xEVMPD (Extended EudraVigilance Medicinal Product Dictionary), and label artwork updates.
Artwork Tracker Management:
- Maintain and manage Artwork Trackers & Systems, ensuring that all artwork PDFs are up-to-date and readily available.
Collaboration & Coordination:
- Liaise with relevant internal teams and external suppliers to assist in the implementation and approval process of labeling and packaging.
- Ensure all packaging designs and changes are in compliance with legislation requirements for each new product or new packaging.

Required Skills & Qualifications:

Experience: Minimum of 4+ years in drug development with a focus on labeling, product package coordination, or clinical supplies/packaging.
Regulatory Knowledge: In-depth understanding of labeling regulations, CCDS, USPI, and experience in packaging compliance.
Document Management: Proficiency in using SPL, electronic document management systems, and handling label submissions.
Lifecycle Management: Hands-on experience in post-approval labeling, PSUR submissions, and safety variations.
Collaboration: Ability to collaborate effectively with internal teams (Tech Ops, Regulatory Affairs) and external suppliers for artwork and packaging development.
Trackers & Systems: Expertise in managing Artwork Trackers and ensuring the availability of up-to-date PDF artwork.

Desired Skills:

Experience in handling xEVMPD and managing label artwork updates.
Ability to manage artwork approval processes for new and modified packaging.
Strong problem-solving skills with the ability to manage multiple projects and deadlines.

Benefits:

#LI-Remote: This position offers remote work flexibility.

This role provides an excellent opportunity for a Regulatory Affairs Specialist to leverage their expertise in labeling, packaging compliance, and regulatory submissions while contributing to the overall success of the product lifecycle.

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Senior Regulatory Affairs Associate- Labeling

Job Description

Job Title: Labeling and Packaging Regulatory Affairs Specialist

Job Description:

Key Responsibilities:

Required Skills & Qualifications:

Desired Skills:

Benefits:

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