Deputy Manager - 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 is responsible for managing all artworks and labeling components for Piramal Critical Care products globally. This role requires meticulous adherence to labeling processes, ensuring compliance with innovator labeling, internal and external partners, and GMP standards. The position involves working within a cross-functional team to ensure labeling documents and change requests are medically and scientifically accurate, regulatory compliant, and aligned with 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 other external partners

Reporting Structure:
Reports to the Regulatory Affairs Labeling Manager

Experience:
4 years of relevant regulatory experience, with global exposure including US, EU, and major Rest of World markets preferred.

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 strong sense of accountability.
Excellent work ethic and a proactive attitude in a dynamic environment.
Project management skills are a plus.

Key Responsibilities:

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

Qualifications:

Bachelor’s or Master’s degree in Pharmaceutical Sciences (B.Pharm, BSc, MPharm, MSc).

About Us:
Piramal Critical Care (PCC), a subsidiary of Piramal Enterprises Limited, is a leading global provider of hospital generics and the third-largest producer of inhaled anesthetics. Committed to delivering critical care solutions, PCC operates in over 100 countries, with a rich product portfolio including inhalation anesthetics like Sevoflurane, Isoflurane, and Halothane, as well as Intrathecal Baclofen therapy for spasticity management.

With state-of-the-art manufacturing facilities in the US and India, PCC has passed rigorous inspections by regulatory bodies such as the US FDA and UK MHRA. The company’s global workforce of over 400 employees is dedicated to expanding PCC’s footprint through new product innovations.

Piramal Group emphasizes corporate social responsibility, partnering with various organizations to support those in need and to care for the environment.

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 qualifications, and we ensure equal opportunities in all personnel matters, including reasonable accommodation for qualified individuals with disabilities and needs related to religious observance or practice.

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Deputy Manager - Labelling Regulatory Affairs

Job Description

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