Drug Regulatory Affairs Job in Noida: The pharmaceutical industry is continuously expanding into global markets, creating a growing demand for professionals with expertise in Drug Regulatory Affairs (DRA). Regulatory Affairs professionals play a critical role in ensuring pharmaceutical products comply with international regulatory standards before reaching global markets.
If you are a B.Pharm or M.Pharm graduate with experience in pharmaceutical regulatory documentation and international market submissions, this opportunity at AMRS Healthcare Pvt Ltd could be an excellent career move.
Drug Regulatory Affairs Job in Noida
AMRS Healthcare Pvt Ltd is currently hiring for the position of:
Executive / Sr. Executive – Drug Regulatory Affairs (DRA)
This role is based in Noida, Sector-132, and offers professionals the opportunity to work on:
- International regulatory submissions
- Dossier preparation
- Global market compliance
- CTD/eCTD documentation
- Lifecycle management activities
Candidates with 1–5 years of experience in Drug Regulatory Affairs are encouraged to apply.
Job Overview Drug Regulatory Affairs Job in Noida
| Particulars | Details |
| Company Name | AMRS Healthcare Pvt Ltd |
| Position | Executive / Sr. Executive – Drug Regulatory Affairs |
| Department | Drug Regulatory Affairs (DRA) |
| Location | Noida, Sector-132, Uttar Pradesh |
| Experience Required | 1–5 Years |
| Qualification | B.Pharm / M.Pharm |
| Job Type | Full-Time |
| Salary | ₹20,000 – ₹35,413 Per Month |
| Work Mode | In-Person |
About AMRS Healthcare Pvt Ltd
AMRS Healthcare Pvt Ltd is involved in pharmaceutical and healthcare operations with a focus on maintaining regulatory compliance and supporting global pharmaceutical markets.
The organization is seeking skilled regulatory professionals capable of handling:
- International dossier submissions
- Regulatory coordination
- Documentation review
- Compliance management
This role provides excellent exposure to global pharmaceutical regulatory systems and international market registration processes.
Why Drug Regulatory Affairs is a High-Growth Career
Drug Regulatory Affairs is one of the fastest-growing career domains in the pharmaceutical industry. As pharmaceutical companies expand into regulated and semi-regulated markets worldwide, the demand for trained DRA professionals continues to increase significantly.
Regulatory Affairs professionals are responsible for:
- Ensuring product approvals
- Managing global submissions
- Maintaining compliance standards
- Coordinating with regulatory authorities
- Supporting product lifecycle activities
Professionals with experience in:
- CTD/eCTD documentation
- Global market submissions
- ICH guidelines
- Regulatory compliance
are highly valued across pharmaceutical organizations worldwide.
Role Overview
The selected candidate will be responsible for ensuring that pharmaceutical products meet all required regulatory standards before they are approved for international markets.
The role involves:
- Preparing regulatory dossiers
- Reviewing technical documents
- Managing submissions
- Coordinating with internal teams
- Supporting regulatory compliance activities
Candidates will work closely with:
- R&D teams
- Quality Assurance (QA)
- Quality Control (QC)
- Manufacturing departments
- Artwork and packaging teams
- Contract manufacturing organizations
Detailed Job Responsibilities
The DRA Executive will perform a wide range of regulatory and compliance-related activities.
Dossier Preparation & Submission
One of the core responsibilities of the role is preparing and submitting pharmaceutical dossiers for international markets.
CTD / ACTD / eCTD Compilation
The candidate will prepare and review:
- CTD dossiers
- ACTD submissions
- eCTD formats
- Country-specific submission formats
The documentation must comply with international regulatory standards and authority-specific requirements.
International Market Submissions
The role includes handling submissions for multiple global regions, including:
LATAM
- Peru
- Chile
- Ecuador
- Colombia
- Bolivia
- Other Latin American markets
Europe
CIS Countries
MENA Region
(Middle East & North Africa)
APAC Region
(Asia-Pacific)
ROW Markets
(Rest of World)
This provides valuable international regulatory exposure for candidates.
Regulatory Documentation Review
The selected candidate will review critical pharmaceutical documentation such as:
- Specifications
- STP (Standard Testing Procedures)
- Stability Data
- Product Validation Protocols (PVP)
- AMV documentation
- Batch Manufacturing Records (BMR)
- Master Formula Records (MFR)
Accurate document review is essential for successful regulatory approvals.
Lifecycle Management Activities
The role also involves post-approval regulatory activities such as:
Variations: Managing updates and modifications in approved dossiers.
Renewals: Handling product registration renewal submissions.
Compliance Updates: Ensuring ongoing compliance with changing regulatory requirements.
Lifecycle management is a crucial function in maintaining product approvals across international markets.
Cross-Functional Coordination
Regulatory Affairs professionals regularly coordinate with multiple departments.
The selected candidate will collaborate with:
- Research & Development (R&D)
- Quality Assurance (QA)
- Quality Control (QC)
- Manufacturing teams
- Contract Manufacturing Organizations (CMOs)
This coordination ensures smooth regulatory submissions and documentation accuracy.
Packaging & Artwork Compliance
The candidate will also work with the artwork and packaging team to:
- Develop compliant packaging materials
- Ensure label accuracy
- Meet country-specific packaging requirements
- Align artwork with dossier submissions
Packaging compliance is an important regulatory requirement in international pharmaceutical markets.
Regulatory Query Handling
The selected candidate will:
- Respond to deficiency letters
- Handle regulatory authority queries
- Support audit observations
- Prepare clarification documents
Strong communication and technical writing skills are important for this responsibility.
Regulatory Documentation Management
Responsibilities also include:
- Maintaining regulatory databases
- Organizing submission records
- Managing document version control
- Ensuring regulatory data integrity
Efficient documentation systems are essential in Regulatory Affairs operations.
Educational Qualification
Candidates must possess:
- Bachelor’s Degree in Pharmacy (B.Pharm)
OR
- Master’s Degree in Pharmacy (M.Pharm)
- Pharm D
Pharmacy educational background is mandatory for this role.
Experience Required
The company is seeking candidates with:
- 1 to 5 years of experience in Drug Regulatory Affairs
Candidates with exposure to:
- International market submissions
- Dossier compilation
- Regulatory documentation
will have an advantage.
Skills Required
The organization is looking for professionals with strong technical and documentation skills.
Technical Skills
Candidates should possess:
- Knowledge of regulatory guidelines
- Understanding of ICH guidelines
- CTD/eCTD/ACTD expertise
- International regulatory awareness
- Dossier preparation experience
Documentation Skills
Strong ability in:
- Technical documentation
- Data organization
- Regulatory formatting
- Submission management
Attention to detail is highly important in regulatory documentation.
Communication & Coordination Skills
The role requires:
- Cross-functional communication
- Coordination with multiple teams
- Professional email communication
- Regulatory query response handling
Why This Opportunity is Valuable
This role provides exposure to:
- Global pharmaceutical regulations
- International product registrations
- Regulatory compliance systems
- Multiple international markets
- Lifecycle management activities
Professionals working in global DRA functions often experience excellent long-term career growth.
Apply NowCareer Growth Opportunities
Drug Regulatory Affairs professionals can progress into roles such as:
- Regulatory Affairs Executive
- Senior DRA Executive
- Regulatory Affairs Manager
- Global Regulatory Specialist
- Compliance Manager
- Dossier Management Lead
- International Regulatory Consultant
Global regulatory expertise is highly valuable in multinational pharmaceutical companies.
Job Location
Noida, Sector-132, Uttar Pradesh
Noida is one of India’s major pharmaceutical and healthcare business hubs, offering excellent professional exposure and career opportunities in:
- Pharmaceuticals
- Clinical Research
- Healthcare Consulting
- Regulatory Affairs
- Biotech Operations
Salary & Benefits
Salary Range: ₹20,000 – ₹35,413 per month
Salary may vary depending on:
- Experience
- Technical expertise
- Regulatory exposure
- Market knowledge
Work Environment
Full-Time Position
In-Person Working Mode
The role offers practical exposure to real-time pharmaceutical regulatory operations and global submission activities.
Why DRA Professionals are in High Demand
As pharmaceutical companies expand globally, regulatory professionals are becoming increasingly important because they:
- Ensure market approvals
- Maintain compliance
- Support international business expansion
- Prevent regulatory risks
- Facilitate product commercialization
Candidates with international regulatory exposure are highly sought after in the pharmaceutical industry.
Tips Before Applying
Before applying, ensure your resume includes:
✔️ International submission experience
✔️ CTD/eCTD handling exposure
✔️ Regulatory software knowledge
✔️ Documentation expertise
✔️ Market exposure (LATAM/MENA/APAC etc.)
✔️ Coordination and communication skills
A well-structured resume improves shortlisting chances.
Final Thoughts
The field of Drug Regulatory Affairs offers stable, respected, and high-growth career opportunities within the pharmaceutical industry. This opening at AMRS Healthcare Pvt Ltd provides an excellent platform for pharmacy professionals to strengthen their expertise in:
- International regulations
- Dossier submissions
- Global compliance systems
- Lifecycle management
If you are passionate about pharmaceutical regulations, documentation, and international market exposure, this role could significantly accelerate your professional growth.
👉 Interested candidates should apply as soon as possible and take the next step toward a successful career in global Drug Regulatory Affairs.
