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Senior Executive - Labelling Regulatory Affairs

4+ years
Not Disclosed
10 Aug. 20, 2024
Job Description
Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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 Description: Regulatory Affairs - Senior Labeling Specialist

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

Job Overview:

As a Senior Labeling Specialist in Regulatory Affairs at Piramal Critical Care, you will oversee all labeling and artwork components for our global product portfolio. Your role is crucial in ensuring that all labeling documents and related change requests are medically and scientifically accurate, comply with regulatory standards, and meet company needs. You will work closely with cross-functional teams to maintain the highest quality and compliance standards in labeling processes.

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, Contract Manufacturing Organizations (CMOs), and other external partners

Reporting Structure:

Reports to the Regulatory Affairs Labeling Manager

Experience Required:

  • Minimum of 4 years of relevant regulatory experience, including global markets such as the US, EU, and major Rest of World regions.

Competencies:

  • Strong interpersonal and organizational skills for effective stakeholder interaction.
  • In-depth knowledge of Health Authority labeling regulations and requirements.
  • Self-directed, motivated, and flexible with a strong work ethic and positive attitude.
  • Project management skills are an advantage.

Key Responsibilities:

  • Global Labeling Compliance: Ensure quality and accuracy in global labeling components including labels, cartons, package inserts, and patient package inserts. Collaborate with cross-functional teams for regulatory submissions and approvals.
  • Document Preparation: Prepare labeling-related documents such as SmPC, PIL, and other texts for submission in the EU region. Create SPL for US Human and Veterinary product submissions, including drug listing and annual registrations.
  • Coordination and Proofreading: Coordinate with stakeholders for timely labeling submissions and resolve related queries. Proofread all types of label copy to ensure accuracy at all stages.
  • Regulatory Compliance: Monitor and process updates to innovator labeling for generic products, ensuring compliance with innovator updates. Coordinate CCDS development and local labeling updates.
  • Central Repository: Develop and maintain a central repository for all labeling components.
  • Promotional Material: Contribute to the development and review of labeling aspects included in promotional materials.

Qualifications:

  • B.Pharma or M.Pharma

About Us:

Piramal Critical Care (PCC), a division of Piramal Pharma Limited (PPL) and part of Piramal Enterprises Limited, is a leading global producer of inhaled anesthetics and a key player in hospital generics. We are committed to providing critical care solutions to patients and healthcare providers worldwide. With a presence in over 100 countries and state-of-the-art manufacturing facilities in the US and India, PCC focuses on sustainable and profitable growth through innovation and expansion.

Piramal Group values ethical practices and inclusive growth, and PCC is dedicated to corporate social responsibility, collaborating with various organizations to support communities and environmental sustainability.

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, veteran status, disability, or any other legally protected characteristic. We base employment decisions on merit and strive to provide equal opportunities in recruitment, selection, training, placement, promotion, and other employment matters.

Join Us:

If you are passionate about regulatory affairs and labeling and seek to be part of a dynamic, global team committed to excellence, we invite you to apply.