Regulatory Affairs Team at AMN Life: Executive Position Open
About AMN Life
Position Details
Skills Required
Job Description
Application Process

Regulatory Affairs Team at AMN Life: Executive Position Open

Are you a detail-oriented professional with a passion for regulatory affairs in the pharmaceutical industry? AMN Life is currently seeking an Executive for their Regulatory Affairs department. If you have experience in preparing technical documents, coordinating with various departments, and ensuring regulatory compliance, this could be your opportunity to contribute to a dynamic company.

About AMN Life

AMN Life is a reputable name in the pharmaceutical industry, known for its commitment to quality and regulatory compliance. With a focus on providing effective healthcare solutions, AMN Life continues to make a positive impact on patients’ lives.

Position Details

As a Regulatory Affairs Executive at AMN Life, you will play a pivotal role in ensuring the accuracy and compliance of technical documents. Here are the key details of the position:

Position: Regulatory Affairs – Executive
Experience: 1 to 5 years
Salary: ₹12,000.00 – ₹725,000.00 per month
Education: M. Pharm/B. Pharm
Schedule: Day shift

Skills Required

To excel in this role, you should possess the following skills:

Preparation of technical documents such as specifications, COA, method of analysis of raw materials and finished products, and stability summary sheets.
Coordinating with different departments within the plant to gather data for document preparation.
Providing technical documents of products to the regulatory team in the corporate office.
Following up on the preparation and testing of samples, both in-house and from external labs.
Maintaining records of technical documents.
Knowledge of regulatory domains and protocols.
Familiarity with dossier preparation and submission in ACTD/CTD/Country Specific format for product registration.
Ability to evaluate and respond to regulatory queries and customer requirements.
Reviewing technical documents, process validation, stability, labeling, batch records, etc., for compliance.
Coordinating with various departments and vendors for documentation and regulatory requirements.

Job Description

Your responsibilities in this role will include:

Dossier preparation, review, and submission in various formats for product registration.
Evaluating and responding to regulatory queries and customer requirements.
Reviewing technical documents and ensuring compliance with regulations.
Coordinating and visiting with respective departments for document samples.
Coordinating with API/PM vendors to address technical queries related to regulatory requirements.
Artwork checking and development for registration and commercial purposes.
Handling local FDA, DCGI, and other regulatory activities.
Ensuring accurate recording and communication of regulatory submissions.