Amarant Lifesciences Pvt. Ltd. is inviting applications for the position of Executive / Senior Executive – Regulatory Affairs in Noida, India. This opportunity is ideal for professionals with 2–4 years of experience in API regulatory submissions, including ASMF, CEP, and DMF filings for global markets such as the US and Europe.
This Regulatory Affairs Executive job in Noida offers a strong career opportunity for candidates with a background in pharmacy, chemistry, or life sciences who want to work on global regulatory dossiers, eCTD publishing, and compliance with ICH guidelines. The role involves collaborating with cross-functional teams and supporting regulatory submissions for international API clients.
Job Overview
- Job Title: Executive / Senior Executive – Regulatory Affairs
- Company: Amarant Lifesciences Pvt. Ltd.
- Location: Noida, Uttar Pradesh, India
- Industry: Pharmaceutical / API Regulatory Affairs
- Job Type: Full Time
- Experience Required: 2–4 Years
- Education: Science degree (Pharmacy, Chemistry, Biochemistry, or related field)
Key Responsibilities
The Regulatory Affairs Executive will support global regulatory activities for API clients, especially targeting US FDA and European regulatory markets.
Main responsibilities include:
- Preparing, reviewing, and submitting API regulatory dossiers for US and EU markets
- Assisting with DMF, CEP, and ASMF submissions, amendments, and regulatory responses
- Performing eCTD compilation, publishing, validation, and lifecycle management
- Coordinating with internal teams and clients to gather regulatory documents
- Maintaining submission trackers, regulatory databases, and documentation systems
- Monitoring regulatory guidelines and ensuring compliance with ICH and global regulatory standards
- Providing regulatory support to clients within defined project timelines
Professionals working in API regulatory affairs jobs in India will gain valuable experience handling international regulatory documentation and submission processes.
Qualifications and Skills
Candidates applying for this Regulatory Affairs job in Noida should meet the following criteria:
Education
- Minimum science degree such as:
- B.Pharm / M.Pharm
- Chemistry
- Biochemistry
- Life sciences or related discipline
Experience
- 2–4 years of experience in API regulatory submissions
- Hands-on knowledge of ASMF, CEP applications, and technical data packages
Skills Required
- Strong understanding of API regulatory documentation
- Familiarity with eCTD submission processes
- Ability to analyze and interpret scientific and regulatory data
- Good written and verbal communication skills
- Proficiency in MS Word and Excel for dossier writing
- Ability to work in cross-functional regulatory teams
Benefits of This Role
Working as a Regulatory Affairs Executive at Amarant Lifesciences offers:
- Exposure to global pharmaceutical regulatory markets
- Hands-on experience with DMF, ASMF, and CEP submissions
- Opportunities to work on international API regulatory projects
- Collaboration with experienced regulatory and scientific teams
- Career growth in pharmaceutical regulatory affairs
How to Apply
Interested candidates who meet the eligibility criteria for this Regulatory Affairs Executive vacancy in Noida can apply by sending their updated resume.
Email: hr1@amarantls.com