Global Regulatory Affairs Manager - Healthcare

Industry - Health and Safety

Skills - Regulatory, ANDA, DCGI, FDA, WHO, 13485

Job Type - Permanent

Description - Develop strategies to ensure smooth and timely launch of products in all countries by ensuring that regulatory approvals are obtained in compliance to regulatory requirements.

Client Details :

Our client is dedicated to improving the health and quality of life of vulnerable people, most of whom live in developing countries. Our client focuses on issues such as malaria, diarrhea diseases, neglected tropical diseases and improving food security through agricultural productivity. They are a 60 year old organization which is headquartered in Europe and have offices/ presence across the globe.

Description :

Reporting to the Global HQ, you will be responsible for :

- Develop regulatory strategies to most efficiently generate data packages for product chemistry, toxicology, environmental and product performance data necessary to receive approvals in a timely manner to meet sales objectives

- Develop templates for major submissions and schedule core registration packages

- Working closely with product delivery teams to formulate regulatory strategies for the products

- Maintain global registration / renewal licenses worldwide

- Develop product labels and language to assure compliance; obtain approvals for these labels

- Analysis, preparation, and execution of all compliance documents for new products

- Prepare and manage annual budget for all regulatory activities

- Work in tandem with business team and ensure smooth launch of products

Profile :

- You will have an experience of about 10-15 years in Regulatory Affairs working with Pharmaceuticals/ Medical Devices industry.

- You will have an experience of handling multiple country regulatory approvals and should have a good idea about product registrations from scratch. You should have an experience managing stakeholders from across the globe.

Job Offer :

Besides a healthy compensation proposal, you will be working with an employer which is dedicated to making the world a better place to live.

Contact - Dinesh Yegireddi

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