About company
Amneal Pharmaceuticals Limited is a U.S.-based Pharmaceutical Company founded by Chirag and Ketan Amin in 2002. The company specializes in the production and development of affordable, high-quality generic drugs across multiple therapeutic categories, such as Parenteral formulations, including injections and other sterile products. For more details about the company, please visit Amneal Pharmaceuticals
Vacancy Details
Amneal Pharmaceuticals Limited has released a notification regarding the hiring of fresh pharma candidates for the job role of Regulatory Affairs Associate. Check out all the details described in the article and apply online.
- DESIGNATION – RA Associate
- DEPARTMENT – Regulatory Affairs
- DIVISION – Document Level Publishing (DLP) Specialist – SIE RA
- EXPERIENCE – Fresher and Experienced (0-2 Years)
Amneal Pharma Regulatory Affairs Job Description
- Prepare and conduct a review of the QC documents for submission purposes.
- Accountable for managing the submission gateway, such as ESG.
- Conduct detailed QC checks of submission dossiers.
- Prepare QC reports and check the reports for any errors.
- Proficiency in using submission software tools such as Extedo, eCTD validator.
- Coordinate with the cross-functional teams, such as Clinical, CMC, and regulatory affairs teams
- Design SOPs provide input to validation and audit procedures related to submissions.
- Capable of prioritizing tasks based on submission timelines and regulatory deadlines
Skills required
- Proficiency in structuring and gathering dossiers as per eCTD and CTD standards.
- Skilled in PDF editing, formatting, and carrying out detailed QC checks to ensure adherence and document integrity.
- Exposure of submission software like Extedo, eCTD Validator, and other relevant eCTD Publishing tools.
- Understanding of global and local regulatory guidelines such as FDA, ICH, and EMA.
- Problem-solving abilities and strong attention to detail.
Qualification Required
- Bachelor’s degree in Pharmacy from a recognized institute in India.
- Master’s degree in Pharmacy (M.Pharm in any specialization)
- Freshers and experienced candidates are both eligible for the job role.
Other Details
- Job Location – Ahmedabad, Gujarat, India
- Contract Type – Full Time
- Work Mode – Onsite
- Industry – Pharmaceutical
Ready to Apply for the Amneal Pharma Regulatory Affairs Job? Here’s How
Candidates completed graduation with a Bachelor’s or Master’s degree in Pharmacy are eligible to apply for the job. Eligible candidates can apply directly by visiting the official website of the company. Freshers and experienced candidates are both eligible to apply for the job. You can directly apply for the job by clicking on the direct link. The direct Link to the application is mentioned below.
Direct Application Link
Interested candidates can apply for the job by submitting the application form, linked below. Make sure you fill in the details carefully and upload the updated resume while applying for the job.
