India's DMPLOI - Jobs & Networking AppEmnar Pharma Private Limited, a leading API & Intermediates Manufacturing Company, is inviting applications from experienced professionals for its Regulatory Affairs Department. Candidates with an M.Sc. in Chemistry and relevant regulatory experience are encouraged to apply for this excellent career opportunity in Hyderabad.
If you have expertise in pharmaceutical regulatory documentation, compliance, and global regulatory submissions, this could be the right opportunity to advance your career.
Job Overview
Particular Details
Company Name
Emnar Pharma Private Limited
Industry
API & Intermediates Manufacturing
Department
Regulatory Affairs
Job Role
Regulatory Affairs Professional
Qualification
M.Sc. Chemistry
Experience
3 Years & Above
Job Location
Sanath Nagar, Hyderabad
Employment Type
Full-Time
About Emnar Pharma
Emnar Pharma Private Limited is a reputed pharmaceutical company engaged in the manufacturing of Active Pharmaceutical Ingredients (APIs) and intermediates. The company operates advanced manufacturing facilities that comply with international regulatory standards, including approvals from agencies such as USFDA, WHO-GMP, EDQM, and KFDA for its manufacturing units.
The company focuses on quality, compliance, innovation, and continuous improvement while serving global pharmaceutical markets.
Key Responsibilities
Prepare and review regulatory dossiers.
Compile CTD/eCTD documentation for global submissions.
Coordinate with QA, QC, Production, and R&D teams.
Handle regulatory queries from health authorities.
Maintain product registration documents.
Ensure compliance with national and international regulations.
Review change controls and regulatory impact assessments.
Support lifecycle management activities.
Eligibility Criteria
Qualification: M.Sc. Chemistry
Experience: Minimum 3 years in Regulatory Affairs
Strong knowledge of pharmaceutical regulatory guidelines.
Good communication and documentation skills.
Experience with API regulatory submissions will be an added advantage.
Required Technical Skills
CTD/eCTD dossier preparation
DMF documentation
ICH Guidelines
GMP and GLP knowledge
Regulatory submissions
Change control management
Pharmaceutical documentation
Global regulatory compliance
Microsoft Office proficiency
Technical report writing
Why Join Emnar Pharma?
Opportunity to work with a leading API manufacturer.
Exposure to international regulatory markets.
Professional growth and learning environment.
Modern R&D and manufacturing facilities.
Competitive salary based on experience.
Career advancement opportunities.
How to Apply
Interested and eligible candidates can send their updated resume to the official HR email IDs.
Email IDs:
rndhr@emnar.com
hr@emnar.com
Job Location: Sanath Nagar, Hyderabad
Apply early, as shortlisted candidates may be contacted before the closing of the recruitment process.
Technical FAQs
1. What is the role of Regulatory Affairs in the pharmaceutical industry?
Regulatory Affairs ensures that pharmaceutical products comply with all applicable national and international regulations before, during, and after marketing authorization.
2. What is a CTD/eCTD submission?
CTD (Common Technical Document) and eCTD (electronic CTD) are internationally accepted formats used for submitting pharmaceutical registration dossiers to regulatory authorities.
3. What is a Drug Master File (DMF)?
A Drug Master File is a confidential document submitted to regulatory agencies containing detailed information about the manufacturing process, quality control, and stability of an API.
4. Which ICH guidelines are important for Regulatory Affairs professionals?
Key ICH guidelines include:
ICH Q1 (Stability)
ICH Q7 (GMP for APIs)
ICH Q8 (Pharmaceutical Development)
ICH Q9 (Quality Risk Management)
ICH Q10 (Pharmaceutical Quality System)
5. What skills are expected from an experienced Regulatory Affairs candidate?
Candidates should have expertise in dossier preparation, regulatory documentation, GMP compliance, ICH guidelines, change control, global submissions, technical writing, and cross-functional coordination.
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