Executive Regulatory Affairs Labelling

Business: Piramal Critical Care
Department: Regulatory Affairs
Location: Kurla
Travel: Low:
**JOB OVERVIEW**:
Responsible for all artworks and labeling components of Piramal Critical Care Products Worldwide with adherence to the labeling processes, ensuring compliance with innovator labeling, internal & external partners, and GMP standards and specifications. 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

**KEY STAKEHOLDERS: INTERNAL**

Cross-Functional: Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Quality Control, Pharmacovigilance, Planning, Project Management, Senior Leadership team

**KEY STAKEHOLDERS: EXTERNAL**

Country Distributors, Health Authority (HA), CMOs and external partners

**REPORTING STRUCTURE**: (Reports To/ Direct Reports Y/N)
- Manager - Labelling

**RELEVANT EXPERIENCE**:
1-2 years relevant regulatory experience (Global experience including US, EU and major Rest of World markets preferred).

**KEY ROLE & RESPONSIBILITIES**
- 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
- Preparation of Labelling related documents ex: SmPC, PIL and Labelling texts for submission in EU region.
- Coordinating with the different stakeholders for timely labeling related submission/approval and query solving.
- Proofreading all types of label copy/annotation/etc. at all developmental stages as well as final label copy to ensure accuracy of labeling
- Creation of SPL for US Human and Vet product submissions, drug listing, annual establishment registration and annual self-identification for GDUFA
- Monitor and process innovator-labeling updates for existing generic products and ensure compliance with innovator updates, including side-by-side comparison with RLDs
- Responsible for coordination of CCDS development and updates of PCC products and coordination of local labeling updates
- Contribute to the development and/or review of all labeling aspects included in Promotional Material.
- Development and maintenance of a central repository for all labeling components

**KEY COMPETENCIES**:

- Must have solid interpersonal and organization skills for interfacing with others.
- Knowledge of Health Authority labeling regulations and requirements.
- Self-directed, motivated, organized, flexible and accountable.
- Excellent work ethic with a positive, can-do attitude to succeed in a fast-paced environment.
- Project management skills is a plus

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.

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 str