Senior Executive - Labelling Regulatory Affairs

Piramal Pharma

4+ years

Not Disclosed

Mumbai

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

Job Title: Regulatory Affairs Specialist – Labeling

Department: Regulatory Affairs
Business Unit: Piramal Critical Care
Location: Kurla, Mumbai
Travel: Low

Job Overview:
The Regulatory Affairs Specialist will oversee all artworks and labeling components for Piramal Critical Care products globally. This role ensures adherence to labeling processes, compliance with innovator standards, and alignment with GMP regulations. The position requires active participation in cross-functional teams to ensure that labeling documents and change requests are medically and scientifically accurate, regulatory compliant, and in line with current global regulations.

Key Stakeholders:

Internal: Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Quality Control, Pharmacovigilance, Planning, Project Management, Senior Management
External: Country Distributors, Health Authorities (HAs), Contract Manufacturing Organizations (CMOs), and external partners

Reporting Structure:
Reports to the Regulatory Affairs Labeling Manager

Experience:
4 years of relevant regulatory experience, with a preference for global experience in US, EU, and major Rest of World markets.

Competencies:

Strong interpersonal and organizational skills for effective collaboration.
In-depth knowledge of Health Authority labeling regulations and requirements.
Self-motivated, organized, and adaptable with a high level of accountability.
Excellent work ethic with a positive, proactive attitude in a dynamic environment.
Project management skills are advantageous.

Key Responsibilities:

Manage global labeling details, including labels, cartons, package inserts, and patient package inserts to ensure compliance, quality, and accuracy. Collaborate with cross-functional teams for regulatory submissions, evaluations, and approvals.
Prepare labeling-related documents, such as SmPC, PIL, and other texts for EU submissions.
Coordinate with stakeholders to ensure timely submission and approval of labeling, and address any related queries.
Proofread all types of label copy and annotations at various developmental stages to ensure accuracy.
Create Structured Product Labeling (SPL) for US Human and Veterinary product submissions, including drug listings, annual establishment registration, and GDUFA self-identification.
Monitor and process innovator-labeling updates for existing generic products, ensuring compliance with innovator updates through side-by-side comparisons with reference listed drugs (RLDs).
Oversee the development and updates of Core Data Sheets (CCDS) for PCC products and manage local labeling updates.
Contribute to the development and review of labeling aspects in promotional materials.
Develop and maintain a central repository for all labeling components.

Qualifications:
B.Pharm or M.Pharm

About Us:
Piramal Critical Care (PCC), a subsidiary of Piramal Enterprises Limited, is a leading global producer of inhaled anesthetics and a prominent player in hospital generics. With operations spanning the USA, Europe, and over 100 countries, PCC offers a range of critical care solutions including Sevoflurane, Isoflurane, Halothane, and Intrathecal Baclofen therapy.

PCC boasts state-of-the-art manufacturing facilities in the US and India, which have successfully passed inspections by regulatory authorities such as the US FDA and UK MHRA. The company’s global workforce of over 400 employees is dedicated to expanding PCC’s reach through innovative product development.

In line with Piramal Group's commitment to corporate social responsibility, PCC actively collaborates with partner organizations to provide support and resources to those in need, while also focusing on environmental stewardship.

Equal Employment Opportunity:
Piramal Group is an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based on race, ethnicity, religion, color, national origin, gender, sexual orientation, gender identity, age, disability, or other legally protected characteristics. Employment decisions are based on merit, and we strive to provide equal opportunities in all personnel matters, including reasonable accommodations for qualified individuals with disabilities and religious practices.

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Senior Executive - Labelling Regulatory Affairs

Job Description

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