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Senior Officer, Regulatory Publishing
full-timeAhmedabad

Summary

Location

Ahmedabad

Type

full-time

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About this role

  • PDF processing, QC Check and CTD/ e-CTD compilation for US market
  • Submission Level Publishing for US Market.
  • Archival and life cycle management of the CTD/e-CTD submission.
  • Priority Management. Understand criticality of any given tasks and discuss any identified issues with Team lead/Group lead.
  • Other duties as assigned by Team lead/Group lead.

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

 

Key roles that the Human Resources team performs:

 

Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.

 

Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.

 

Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.

 

Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.

 

Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.


Other facts

Tech stack
PDF Processing,QC Check,CTD Compilation,E-CTD Compilation,Submission Level Publishing,Archival Management,Life Cycle Management,Priority Management,Team Collaboration,Issue Discussion

About Amneal India

Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.

Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.

Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.

Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.

Team size: 5,001-10,000 employees
LinkedIn: Visit
Industry: Pharmaceutical Manufacturing
Founding Year: 2002

What you'll do

  • The Senior Officer will handle PDF processing, quality checks, and CTD/e-CTD compilation for the US market. They will also manage archival and life cycle management of submissions and prioritize tasks effectively.

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Frequently Asked Questions

What does a Senior Officer, Regulatory Publishing do at Amneal India?

As a Senior Officer, Regulatory Publishing at Amneal India, you will: the Senior Officer will handle PDF processing, quality checks, and CTD/e-CTD compilation for the US market. They will also manage archival and life cycle management of submissions and prioritize tasks effectively..

Why join Amneal India as a Senior Officer, Regulatory Publishing?

Amneal India is a leading Pharmaceutical Manufacturing company.

Is the Senior Officer, Regulatory Publishing position at Amneal India remote?

The Senior Officer, Regulatory Publishing position at Amneal India is based in Ahmedabad, Gujarat, India. Contact the company through Clera for specific work arrangement details.

How do I apply for the Senior Officer, Regulatory Publishing position at Amneal India?

You can apply for the Senior Officer, Regulatory Publishing position at Amneal India directly through Clera. Click the "Apply Now" button above to start your application. Clera's AI-powered platform will help match your profile with this opportunity and guide you through the application process. You can also learn more about Amneal India on their website.