andheri mumbai maharashtra pharmaceutical regulatory affairs Jobs – 48 Open Jobs Today

Executive Labelling - Regulatory Affairs
Piramal Pharma Limited —Mumbai, Maharashtra
- Full-time
- Master's degree
- Project management
- Bachelor's degree
7d
Head of Regulatory Affairs ASIA
Roquette —Mumbai, Maharashtra
- Full-time
2d
M-Regulatory Affairs
Genpact India Pvt. Ltd. —Mumbai, Maharashtra
- Full-time
- English
- Microsoft Office
- Master's degree
Quick apply
Regulatory Affairs Specialist
Jobskey —Mumbai, Maharashtra
- ₹12,00,000 - ₹15,00,000 a year
- Full-time
- Master's degree
- Bachelor's degree
- Team management
Quick apply
Regulatory Affairs Executive
Advika Enterprises —Navi Mumbai, Maharashtra
- ₹30,009 - ₹60,000 a month
- Full-time
- Microsoft Office
- Analysis skills
- Bachelor's degree
Quick apply
Lead Regulatory Affairs
AstraZeneca —Mumbai, Maharashtra
- Full-time
- Management
- Bachelor's degree
Executive Regulatory Affairs
Ecolux Enterprises —Vile Parle, Mumbai, Maharashtra
- ₹25,000 - ₹41,000 a month
- Full-time
- B.Sc
- Master's degree
- Bachelor's degree
- Health insurance
- Life insurance
Quick apply
Regulatory Operations Associate
BGBx —Mumbai, Maharashtra
- ₹8,50,000 - ₹11,00,000 a year
- Monday to Friday
- Remote
- Microsoft Office
- Project management
- Bachelor's degree
Quick apply
2d
Regulatory Affairs Associate III
Teva Pharmaceuticals —Navi Mumbai, Maharashtra
- Laboratory experience
- Communication skills
- Health insurance
12d
Lead Associate – Regulatory Affairs
Genpact India Pvt. Ltd. —Mumbai, Maharashtra
- Full-time
- Hybrid work
- Medicine
- English
- Master's degree
Quick apply
Executive/ Sr. Executive Regulatory Affairs
Orion Corporation —Mumbai, Maharashtra
- Email
- Hybrid work
- English
- Microsoft Office
- Master's degree
6d
Senior Regulatory Affairs Executive
Artevet Therapeutics Pvt. Ltd. —Vile Parle, Mumbai, Maharashtra
- ₹4,00,000 - ₹5,50,000 a year
- Full-time
- Bachelor's degree
- In-person
- Manufacturing
Quick apply
Manager Regulatory Affairs
Africure Pharmaceuticals —Mumbai, Maharashtra
- ₹5,00,000 - ₹7,00,000 a year
- B.Sc
- English
- Bachelor's degree
Regulatory Affairs manager (Pharma)
Concept Pharmaceuticals Ltd —Andheri, Mumbai, Maharashtra
- From ₹45,000 a month
- Full-time
- Bachelor's degree
- In-person
Quick apply
5d
Regulatory Affairs Associate II
Teva Pharmaceuticals —Navi Mumbai, Maharashtra
- Laboratory experience
- Computer skills
- Communication skills
- Health insurance
1d
Asst. Manager / Manager – Regulatory Affairs
Client of Nitya Consulting —Andheri, Mumbai, Maharashtra
- ₹10,00,000 - ₹15,00,000 a year
- Email
- English
- Bachelor's degree
- In-person
Quick apply
7d
Regulatory Affairs Manager
Pharmanovia —Mumbai, Maharashtra
- Microsoft Powerpoint
- Microsoft Outlook
- English
Lead Consultant – Regulatory Affairs
Genpact India Pvt. Ltd. —Mumbai, Maharashtra
- Full-time
- Hybrid work
- English
- Microsoft Office
- Master's degree
Quick apply
Regulatory & Compliance Associate. Skyleaf consultants
Skyleaf Consultants —Mumbai, Maharashtra
- ₹8,00,000 - ₹10,00,000 a year
- Full-time
- Research
- Communication skills
Regulatory Affairs Executive
Merit Organics Limited —Mumbai, Maharashtra
- ₹25,000 - ₹45,000 a month
- Full-time
- Bachelor's degree
- In-person
- Communication skills
Quick apply

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Executive Labelling - Regulatory Affairs

Piramal Pharma Limited -
Mumbai, Maharashtra

Apply Now

Job details

Full-time
7 days ago

Qualifications

Master's degree
Project management
Quality assurance
Bachelor's degree

Full job description

Be the First to Apply

Division

Piramal Critical Care

Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders.

PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management.

PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs.

For more details, please visit https://www.piramalcriticalcare.com/global/

Job Title

Executive Labelling - Regulatory Affairs

Job Description

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

Business: Piramal Critical Care

Department: Regulatory Affairs

Location: Kurla

Travel: Low

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: Directly reports to Manager – Labelling

Essential Qualification:

Bachelor’ degree or Master’s degree in Pharmaceutical sciences or equivalent

Experience:

4 years relevant regulatory experience (Global experience including US, EU and major Rest of World markets preferred)

Roles and 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 labelling

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

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

Apply Now

Refine Your Search

pharmaceutical regulatory affairs jobs in andheri mumbai maharashtra

Executive Labelling - Regulatory Affairs

Head of Regulatory Affairs ASIA

M-Regulatory Affairs

Regulatory Affairs Specialist

Regulatory Affairs Executive

Lead Regulatory Affairs

Executive Regulatory Affairs

Regulatory Operations Associate

Regulatory Affairs Associate III

Lead Associate – Regulatory Affairs

Executive/ Sr. Executive Regulatory Affairs

Senior Regulatory Affairs Executive

Manager Regulatory Affairs

Regulatory Affairs manager (Pharma)

Regulatory Affairs Associate II

Asst. Manager / Manager – Regulatory Affairs

Regulatory Affairs Manager

Lead Consultant – Regulatory Affairs

Regulatory & Compliance Associate. Skyleaf consultants

Regulatory Affairs Executive

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