Synthimed Hiring Drug Regulatory Affairs
- Company Overview
- Job Role & Responsibilities
- Key Responsibilities
- Eligibility / Qualifications
- Educational Qualification
- Relevant Courses (comma-separated)
- Experience Requirements
- Additional Eligibility Notes
- Location & Salary
- Application Process
- Why This Role Matters in Pharma & Healthcare
- Frequently Asked Questions (FAQs)
- Is this job open for freshers?
- Is API industry experience mandatory?
- Are female candidates eligible?
- What qualifications are required?
- Where is the job location?
- How do I apply?
- Summary Table
B.Pharm/M.Pharm DRA Vacancy (2–5 yrs) – Derabassi
B.Pharm/M.Pharm Drug Regulatory Affairs vacancy with 2–5 years experience in API pharma at Derabassi. Experienced candidates only.
Synthimed is strengthening its regulatory operations and is urgently hiring experienced professionals for its Drug Regulatory Affairs (DRA) team at Derabassi. This opportunity is designed for candidates with hands-on exposure to the API pharmaceutical industry who are ready to take ownership of regulatory submissions, compliance activities, and global dossier management. If you have strong regulatory knowledge and want to work in a quality-driven, compliance-focused environment, this role offers long-term career stability and professional growth.
Company Overview
Synthimed is an emerging name in the active pharmaceutical ingredients (API) segment, operating with a strong focus on regulatory compliance, quality systems, and global market readiness. The company supports regulated and semi-regulated markets by maintaining robust documentation practices, strict adherence to regulatory guidelines, and a culture of continuous improvement.
With increasing regulatory expectations across global health authorities, Synthimed’s Drug Regulatory Affairs function plays a critical role in ensuring product approvals, lifecycle compliance, and smooth coordination with international regulatory bodies. Joining the DRA team means contributing directly to patient safety, product integrity, and sustainable pharma growth.
Job Role & Responsibilities
The Drug Regulatory Affairs professional will be responsible for managing end-to-end regulatory activities related to API products. The role requires close coordination with QA, QC, R&D, and manufacturing teams to ensure timely submissions and regulatory compliance.
Key Responsibilities
- Preparation, compilation, and review of regulatory dossiers for APIs in CTD/eCTD formats
- Handling regulatory submissions, responses, and deficiency management for global markets
- Coordination with internal departments for data collection, document review, and compliance alignment
- Preparation and maintenance of Drug Master Files (DMFs), amendments, and annual updates
- Managing regulatory queries, variations, and lifecycle management activities
- Ensuring compliance with current regulatory guidelines (ICH, WHO, USFDA, EMA as applicable)
- Supporting audits, inspections, and regulatory commitments
- Tracking regulatory changes and assessing impact on existing products
- Maintaining accurate regulatory databases, trackers, and documentation systems
This role demands precision, regulatory intelligence, and strong documentation skills, making it ideal for professionals seeking high-responsibility regulatory careers in pharma.
Eligibility / Qualifications
Educational Qualification
- B.Pharm, M.Pharm
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
- Exposure to regulatory submissions and DMF handling is essential
Additional Eligibility Notes
- This position is strictly for experienced professionals
- Freshers are not eligible for this role
- Female candidates are encouraged to apply, supporting diversity in regulatory sciences
Location & Salary
- Job Location: Derabassi
- Industry: API Pharmaceutical Manufacturing
- Salary: Best in industry, commensurate with experience and regulatory expertise (not disclosed)
Derabassi is a growing pharma hub offering stable industrial infrastructure and strong career opportunities in regulatory and compliance functions.
Application Process
Interested and eligible candidates should apply through the official contact details provided by the company.
- Email: astha.trivedi@synthimed.com
- Contact Number: 8968374200
Candidates are advised to mention their total experience, API regulatory exposure, and current location clearly in their CV or email subject line for faster shortlisting.
Why This Role Matters in Pharma & Healthcare
Drug Regulatory Affairs professionals are the backbone of pharmaceutical compliance and global market access. This role directly contributes to ensuring safe, effective, and compliant API supply chains that support finished dosage manufacturers worldwide. By joining Synthimed’s DRA team, you become part of a function that safeguards regulatory integrity and supports global healthcare systems.
Frequently Asked Questions (FAQs)
Is this job open for freshers?
No. This position is strictly for experienced professionals with 2–5 years of API regulatory experience.
Is API industry experience mandatory?
Yes. Candidates must have prior experience in the API pharmaceutical industry.
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 role is based at Derabassi.
How do I apply?
You can send your updated CV to astha.trivedi@synthimed.com or contact 8968374200 for further details.
Summary Table
| Company | Synthimed |
|---|---|
| Vacancies | Drug Regulatory Affairs (DRA) |
| Required Education | B.Pharm, M.Pharm |
| Experience | 2–5 Years (API Pharma Mandatory) |
To apply for this job email your details to astha.trivedi@synthimed.com
