Piramal Hiring for Manager – Labelling -Apply Now
Manager – Labelling
Mumbai, Maharashtra, India
Job Description
Business: Piramal Critical Care
Department: Regulatory Affairs
Location: Kurla, Mumbai
Travel: Low
JOB OVERVIEW:
Responsible for all artworks and labeling components of Piramal Critical Care Products Worldwide with adherence to the labeling processes to ensure compliance with innovator labeling, internal company, external partners and GMP standards and specifications. Will participate in a cross-functional team environment as necessary to ensure labeling documents and associated change requests are medically and scientifically accurate and that they comply with regulatory standards, meet company needs and accurately assess current strategy and global regulations.
REPORTING STRUCTURE:
Compliance Director, Regulatory Affairs
RELEVANT EXPERIENCE:
- Knowledge of global regulatory labeling requirements (Global experience, including US, EU and major Rest of the World Markets preferred)
- Possess ability to multi-task, establish priorities and mentor junior regulatory staff while working in a fast paced environment
- Must demonstrate leadership skill and an ability to interact with multiple key stakeholders at a senior level
- Possess excellent written and verbal communication skills
- Experience working with SharePoint and Harmony
- Minimum of 10 years of direct Regulatory Affairs experience with detailed understanding of labelling and artwork.
- Minimum of 8 years direct managerial experience
KEY ROLE & RESPONSIBILITY :
Depending on relevant experience, job responsibilities may include, but are not restricted to:
- Global labeling details (labels, cartons, package inserts, patient package inserts) to ensure quality and accurate compliance, evaluations, maintenance, reviews and approvals with cross-functional teams for regulatory submissions. Regions covered: EU, LATAM, ROW and US.
- Proofreading all types of label copy/annotation/etc. at all developmental stages as well as final label copy to ensure accuracy of labeling.
- Coordination with Graphics, Purchasing, Sales, Supply Chain, Manufacturing and Regulatory Affairs teams by attending weekly calls to execute the order within committed timelines
- Preparation of Labelling related documents e.g. SmPC, PIL and Labelling texts for submission in EU region.
- Creation of SPL for US Human and Vet product submissions, drug listing, annual establishment registration and annual self-identification for GDUFA.
- Support to manufacturing sites for order execution by providing documentation support and resolve issues as and when they occur
- Ensure all electronic databases used for the storage and management of product information, including artworks, are correctly and accurately updated within a timely manner to ensure full compliance with GMP requirements
- Support the Regulatory Affairs department in audit readiness and during audits, as required
- Support the Regulatory Affairs Compliance Director during investigations into non-conformances, including route cause analysis and implementation of identified corrective and preventative actions
- Create/revise SOPs and work instructions for labeling (including global harmonization of labeling SOPs).
- Drive to meet business targets
- Demonstrable commitment to:
- attention to detail;
- team working; and
- personal accountability
Qualifications
ESSENTIAL QUALIFICATION:
BSc, B Pharm or MSc degree in a scientific discipline
About Us
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
About the Team
Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics. Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe, PCC is committed to enabling sustainable and profitable growth for all its stakeholders.
PCC maintains a wide presence across the USA, Europe and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators.
Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. PCC is focused on further expanding its global footprint through new product additions in the critical care space.
Committed to corporate social responsibility alongside Piramal Group, PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need, as well as caring for the environment.
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Job Info
- Job Identification6729
- Job Category Regulatory Affairs
- Posting Date10/09/2024, 07:28 PM
- Apply Before01/31/2025, 07:27 PM
- Job ScheduleFull time
- Locations Project : Piramal Agastya, PRL Agastya Pvt Ltd., LBS Marg, Kamani Junction,, Mumbai, Maharashtra, 400070, IN
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