The pharmaceutical industry is expanding rapidly, creating exciting career opportunities for Regulatory Affairs (RA) professionals with experience in global markets. If you have expertise in preparing regulatory dossiers, handling USFDA or UKMHRA submissions, and ensuring compliance with international pharmaceutical regulations, this is an excellent opportunity.

Symbiotec Pharmalab Pvt. Ltd. has announced urgent hiring for experienced Regulatory Affairs professionals at its Rau, Indore (Madhya Pradesh) facility. The company is looking for candidates with experience in API, Formulations, and Fermentation regulatory documentation for regulated international markets.

🏢 About Symbiotec Pharmalab

Symbiotec Pharmalab Pvt. Ltd. is one of India’s leading pharmaceutical manufacturers specializing in Corticosteroids and Steroid Hormone APIs. The company exports pharmaceutical products to more than 40 countries and operates manufacturing facilities approved by major global regulatory authorities, including:

✅ USFDA
✅ EU-GMP
✅ WHO-GMP

Symbiotec offers employees exposure to international regulatory projects, advanced pharmaceutical manufacturing, and global compliance systems.

Job Details

Particulars	Details
Company	Symbiotec Pharmalab Pvt. Ltd.
Department	Regulatory Affairs
Job Location	Rau, Indore, Madhya Pradesh
Business Segment	API, Formulations & Fermentation
Qualification	B.Pharm, M.Pharm, B.Sc, M.Sc
Experience	Candidates with US/UK Regulatory Affairs experience
Regulated Markets	USFDA & UKMHRA
Application Mode	Email

Educational Qualification

Candidates should possess any of the following qualifications:

B.Pharm
M.Pharm
B.Sc (Chemistry/Life Sciences)
M.Sc (Chemistry, Biotechnology, Life Sciences)

Experience Required

Applicants should have experience in:

Regulatory Affairs
API Regulatory Documentation
Formulation Regulatory Affairs
Fermentation Regulatory Affairs
USFDA documentation
UKMHRA submissions
eCTD documentation
CMC documentation
DMF preparation
ANDA submissions

Key Responsibilities

Selected candidates will be responsible for:

📄 Dossier Preparation

Preparation of Drug Master Files (DMF)
ANDA dossier compilation
CTD/eCTD documentation
Product lifecycle documentation

🔍 Documentation Review

Reviewing R&D documentation
Verifying QC and QA reports
Checking analytical data
Ensuring document accuracy before submission

🌍 Regulatory Compliance

Monitoring updates from USFDA
Following UKMHRA regulatory guidelines
Maintaining global regulatory compliance

💬 Regulatory Query Handling

Preparing responses to deficiency letters
Supporting regulatory inspections
Coordinating with internal departments

Skills Required

Candidates should possess:

Strong documentation skills
Knowledge of DMF & ANDA
Experience with eCTD software
Understanding of CMC documentation
Excellent analytical ability
Good communication skills
Attention to detail
Team collaboration skills

Why Join Symbiotec Pharmalab?

✔ Global pharmaceutical organization

✔ International regulatory exposure

✔ Work on USFDA & UKMHRA projects

✔ Opportunity to handle global submissions

✔ Excellent career growth in Regulatory Affairs

✔ Modern manufacturing facilities

How the Regulatory Affairs Process Works

A Regulatory Affairs professional typically follows these stages:

1️⃣ Data Collection

Gather manufacturing documents
Collect analytical reports
Compile stability data
Organize validation documents

2️⃣ Compliance Review

Review documentation against USFDA guidelines
Check UKMHRA requirements
Verify regulatory completeness

3️⃣ Dossier Compilation

Prepare CTD Modules
Compile DMF/ANDA submissions
Conduct final quality checks
Submit electronic dossiers

How to Apply

Interested candidates can send their updated resume to:

📧 Email: vinita.sarkar@symbiotec.com

📞 HR Contact: Vinita

📱 Mobile: +91 96300 90603

Tips Before Applying

Use a professional email subject such as:
Application for Regulatory Affairs – API – 3 Years Experience
Mention your experience with:
- DMF
- ANDA
- eCTD
- USFDA
- UKMHRA
- CMC documentation
Include:
- Current CTC
- Expected CTC
- Notice Period
- Current Location

Symbiotec Pharmalab Mega Recruitment 2026: Regulatory Affairs Jobs in Rau, Indore | Apply Now