Drug Regulatory Affairs Jobs at Synthimed
Introduction
Experienced regulatory professionals looking to build a stable and high-responsibility career in the API pharmaceutical sector now have a strong opportunity to join a growing organization. Synthimed is actively expanding its Drug Regulatory Affairs function and is hiring skilled professionals with hands-on API regulatory exposure. This role is ideal for candidates who are confident in global submissions, DMF management, and regulatory compliance activities.
The position offers long-term career growth in a compliance-driven environment where regulatory expertise directly impacts global healthcare supply chains. Drug Regulatory Affairs Jobs at Synthimed
Company Overview
Synthimed Labs Pvt Ltd is a developing pharmaceutical organization focused on the manufacturing and regulatory compliance of active pharmaceutical ingredients (APIs). The company supports both regulated and semi-regulated markets by maintaining strong documentation practices, quality systems, and adherence to international regulatory guidelines. Drug Regulatory Affairs Jobs at Synthimed
With increasing global regulatory scrutiny, Synthimed continues to strengthen its Drug Regulatory Affairs team to ensure product approvals, lifecycle compliance, and sustained market access. The organization promotes a culture of accountability, quality, and continuous improvement. Drug Regulatory Affairs Jobs at Synthimed
Job Role & Responsibilities
The Drug Regulatory Affairs professional will manage regulatory activities for API products and act as a key link between internal departments and global regulatory authorities. The role requires accuracy, regulatory awareness, and the ability to handle complex documentation independently. Drug Regulatory Affairs Jobs at Synthimed
Key Responsibilities
- Preparation, compilation, and review of API regulatory dossiers in CTD / eCTD formats
- Handling regulatory submissions, responses, and deficiency letters for global markets
- Coordination with QA, QC, R&D, and manufacturing teams for data collection and document alignment
- Preparation, maintenance, and lifecycle management of Drug Master Files (DMFs)
- Managing amendments, variations, and annual updates to regulatory submissions
- Ensuring compliance with applicable regulatory guidelines such as ICH, WHO, USFDA, EMA (as applicable)
- Supporting regulatory audits, inspections, and post-approval commitments
- Monitoring regulatory updates and evaluating their impact on existing and upcoming products
- Maintaining accurate regulatory trackers, databases, and submission records
- Ensuring timely and compliant execution of all regulatory activities
This role is well-suited for professionals who prefer ownership-driven regulatory work within the API pharmaceutical industry. Drug Regulatory Affairs Jobs at Synthimed
Eligibility / Qualifications
Educational Qualification
- B.Pharm or M.Pharm from a recognized institution
Relevant Courses (comma-separated)
B.Pharm, M.Pharm, Pharmaceutical Regulatory Affairs, Regulatory Sciences, Industrial Pharmacy, Quality Assurance, Pharmaceutical Analysis
Experience Requirements
- 2 to 5 years of relevant experience in Drug Regulatory Affairs
- Mandatory experience in the API pharmaceutical industry
- Practical exposure to regulatory submissions and DMF handling is essential
Additional Eligibility Notes
- This role is strictly for experienced professionals
- Freshers are not eligible for this position
- Female candidates are encouraged to apply, supporting diversity in regulatory sciences
Location & Salary
- Job Location: Derabassi, Punjab
- Industry: API Pharmaceutical Manufacturing
- Employment Type: Full-time
- Salary: As per company norms (best in industry, based on experience and regulatory expertise)
Derabassi is a rapidly growing pharmaceutical hub offering stable infrastructure and long-term opportunities in regulatory and compliance functions. Drug Regulatory Affairs Jobs at Synthimed
Application Process
Interested and eligible candidates can apply directly using the official contact details provided by the company.
- Email: astha.trivedi@synthimed.com
- Contact Number: 8968374200
Candidates are advised to clearly mention:
- Total years of experience
- API regulatory exposure
- Current location
in their CV or email subject line to ensure faster shortlisting.
Why This Role Matters in Pharma & Healthcare
Drug Regulatory Affairs professionals play a critical role in ensuring that pharmaceutical products meet global quality, safety, and compliance standards. In the API sector, regulatory accuracy directly impacts the supply of safe medicines worldwide. By joining Synthimed’s DRA team, you contribute to maintaining regulatory integrity, supporting finished dosage manufacturers, and strengthening global healthcare systems through compliant API supply chains. Drug Regulatory Affairs Jobs at Synthimed
Frequently Asked Questions (FAQs)
Is this job open for freshers?
No. This role is only for candidates with 2–5 years of relevant API regulatory experience.
Is API industry experience mandatory?
Yes. Prior experience in the API pharmaceutical industry is compulsory.
Are female candidates eligible?
Yes. Female candidates are strongly encouraged to apply.
What qualifications are required?
B.Pharm or M.Pharm is mandatory.
Where is the job location?
The position is based in Derabassi, Punjab.
How do I apply?
You can email your CV to astha.trivedi@synthimed.com or contact 8968374200 for further details.
Summary Table
| Details | Information |
|---|---|
| Company | Synthimed |
| Job Role | Drug Regulatory Affairs |
| Education Required | B.Pharm / M.Pharm |
| Experience | 2–5 Years (API Pharma Mandatory) |
| Job Type | Full-time |
| Location | Derabassi |
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform and is not affiliated with Synthimed or any pharmaceutical company. All job details are shared for informational purposes only. Candidates should verify information and apply through official communication channels. Drug Regulatory Affairs Jobs at Synthimed
Final Call-to-Action
If you have strong API regulatory experience and are looking for a responsible, growth-oriented role in Drug Regulatory Affairs, this opportunity at Synthimed can be the right next step. Apply promptly to secure your chance to work in a compliance-focused pharmaceutical environment. Drug Regulatory Affairs Jobs at Synthimed
