Regulatory Affairs Executive Job at Amarant Lifesciences in Noida for DMF, ASMF, CEP submissions and eCTD publishing roles.
Introduction
Professionals looking to advance their careers in pharmaceutical regulatory affairs can explore this opportunity at Amarant Lifesciences Pvt. Ltd. The company is currently inviting applications for the role of Executive / Senior Executive – Regulatory Affairs at its Noida office in Uttar Pradesh.
This role is suitable for candidates who have experience working with API regulatory submissions and global regulatory documentation, particularly for international markets such as the United States and Europe. The selected candidate will contribute to preparing regulatory dossiers, managing submission documentation, and ensuring compliance with international regulatory guidelines.
Working in this role provides valuable exposure to global regulatory systems including DMF, CEP, and ASMF submissions, which are essential components of pharmaceutical product registrations. Regulatory Affairs Executive Job at Amarant Lifesciences
Company Overview
Amarant Lifesciences Pvt. Ltd. is a pharmaceutical services and consulting organization specializing in regulatory affairs support for active pharmaceutical ingredients (APIs). The company works with pharmaceutical manufacturers and clients worldwide to support regulatory submissions, compliance documentation, and product registration processes.
With increasing regulatory requirements across international markets, Amarant Lifesciences assists clients in preparing high-quality regulatory dossiers and managing submission workflows. The company focuses on maintaining compliance with international regulatory standards including guidelines issued by regulatory authorities such as the US FDA and European agencies.
Professionals working with Amarant Lifesciences gain hands-on experience in global regulatory processes and regulatory documentation management. Regulatory Affairs Executive Job at Amarant Lifesciences
Job Overview
| Job Details | Information |
|---|---|
| Company Name | Amarant Lifesciences Pvt. Ltd. |
| Job Role | Executive / Senior Executive – Regulatory Affairs |
| Department | Regulatory Affairs |
| Industry | Pharmaceutical / API Regulatory |
| Job Location | Noida, Uttar Pradesh, India |
| Employment Type | Full-Time |
| Experience Required | 2 – 4 Years |
| Qualification | B.Pharm / M.Pharm / Chemistry / Biochemistry / Life Sciences |
| Application Mode | Email Application |
Job Location & Employment Type
The Regulatory Affairs Executive position is based in Noida, Uttar Pradesh.
This is a full-time role within the Regulatory Affairs department, focusing on regulatory documentation and submission support for global pharmaceutical markets.
The selected candidate will collaborate with internal teams and international clients to manage regulatory submissions and maintain regulatory compliance. Regulatory Affairs Executive Job at Amarant Lifesciences
Open Positions / Department Details
Position: Executive / Senior Executive – Regulatory Affairs
Department: API Regulatory Affairs
The Regulatory Affairs department is responsible for preparing regulatory dossiers, managing submission processes, and ensuring pharmaceutical products comply with international regulatory standards.
Professionals in this department work on documentation required for product registrations and regulatory approvals in global markets.
Key Roles & Responsibilities
Preparation of Regulatory Dossiers
The selected candidate will assist in preparing regulatory dossiers for API products intended for submission to international regulatory authorities. Regulatory Affairs Executive Job at Amarant Lifesciences
This includes compiling scientific data, technical documentation, and supporting regulatory materials.
DMF, ASMF, and CEP Submissions
A major responsibility of the role involves supporting regulatory submissions such as:
- Drug Master File (DMF) submissions for the United States market
- Active Substance Master File (ASMF) submissions for European markets
- Certificate of Suitability (CEP) applications for regulatory compliance
The candidate may also assist with submission amendments and responses to regulatory authority queries.
eCTD Compilation and Publishing
The Regulatory Affairs Executive will work on electronic Common Technical Document (eCTD) submissions. This includes compiling, publishing, validating, and managing lifecycle updates of regulatory submissions.
Regulatory Documentation Management
Maintaining regulatory documentation and submission trackers is an important part of the role. Proper documentation helps ensure submission timelines and regulatory requirements are met.
Cross-Functional Coordination
The candidate will coordinate with internal departments such as quality assurance, research and development, and manufacturing teams to gather required documentation for regulatory submissions.
Regulatory Compliance Monitoring
The role involves monitoring regulatory guidelines and ensuring that documentation and submission processes comply with ICH guidelines and global regulatory requirements.
Client Support and Communication
The Regulatory Affairs Executive may provide regulatory support to international clients by assisting with submission preparation and regulatory documentation requirements.
Eligibility Criteria
Candidates interested in applying for this role should meet the following requirements.
Education
Applicants must possess a science-related degree such as:
- Bachelor of Pharmacy (B.Pharm)
- Master of Pharmacy (M.Pharm)
- Chemistry
- Biochemistry
- Life Sciences or related disciplines
Experience
- 2 to 4 years of professional experience in API regulatory affairs or regulatory submission processes
- Experience working with regulatory dossiers for international markets is preferred.
Skills Required
Ideal candidates should demonstrate the following competencies:
- Knowledge of API regulatory documentation and submission processes
- Familiarity with eCTD submission formats and publishing tools
- Understanding of DMF, ASMF, and CEP applications
- Ability to analyze regulatory and scientific documentation
- Strong written and verbal communication skills
- Proficiency in MS Word and Excel for documentation management
- Ability to work effectively with cross-functional teams
Salary & Benefits
The salary package for this role has not been publicly disclosed and will be as per company norms.
Employees working at Amarant Lifesciences may benefit from:
- Exposure to global pharmaceutical regulatory markets
- Hands-on experience with international regulatory submissions
- Opportunities to work on complex API regulatory projects
- Professional development in regulatory affairs and compliance
Regulatory Affairs Executive Job at Amarant Lifesciences
Selection Process
The recruitment process may include the following steps:
- Resume Screening
- Technical Interview (regulatory affairs knowledge)
- HR Discussion
- Final Selection
Shortlisted candidates will be contacted by the company’s recruitment team. Regulatory Affairs Executive Job at Amarant Lifesciences
How to Apply
Candidates interested in the Regulatory Affairs Executive / Senior Executive role at Amarant Lifesciences Pvt. Ltd. can apply by sending their updated resume via email. Regulatory Affairs Executive Job at Amarant Lifesciences
Email Application
Applicants should ensure that their resumes highlight:
- Experience in regulatory submissions and documentation
- Knowledge of DMF, ASMF, or CEP submissions
- Familiarity with eCTD publishing and regulatory guidelines
Providing detailed regulatory affairs experience can improve the chances of being shortlisted. Regulatory Affairs Executive Job at Amarant Lifesciences Regulatory Affairs Executive Job at Amarant Lifesciences
Important Dates
- Job Posted: March 14, 2026
- Application Deadline: Not specified
Candidates are encouraged to apply as soon as possible.
Why Apply for This Pharma Job?
Regulatory affairs roles provide valuable opportunities to work on pharmaceutical product registrations and global regulatory compliance. Professionals in this field develop expertise in preparing regulatory dossiers, managing submission workflows, and interacting with international regulatory authorities.
Working with Amarant Lifesciences allows candidates to gain hands-on experience in global API regulatory submissions, which can open career opportunities in regulatory affairs leadership, regulatory consulting, and international pharmaceutical compliance roles. Regulatory Affairs Executive Job at Amarant Lifesciences
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform that shares pharmaceutical and healthcare job updates for informational purposes only.
We do not conduct recruitment or charge any fees for job applications. Candidates should verify job details directly with the company before applying. IndiaPharmaJobs.in is not affiliated with Amarant Lifesciences Pvt. Ltd. or any other organization mentioned in the job postings. Regulatory Affairs Executive Job at Amarant Lifesciences
Final Call-to-Action
Candidates with experience in API regulatory affairs and global regulatory submissions should consider applying for this opportunity. Send your updated resume to the provided email address and highlight your experience in regulatory documentation, eCTD submissions, and international regulatory guidelines to improve your chances of being shortlisted for the Regulatory Affairs Executive role at Amarant Lifesciences Pvt. Ltd. Regulatory Affairs Executive Job at Amarant Lifesciences
