Synthimed Labs Pvt. Ltd. is a growing pharmaceutical organization focused on quality manufacturing and regulatory excellence. The company is strengthening its Regulatory Affairs (API) team at its Derabassi facility to support expanding global compliance and documentation requirements.
Job Details – Drug Regulatory Affairs (DRA)
- Role: Drug Regulatory Affairs (DRA) – API
- Experience Required: 4–10+ years
- Vacancies: 02
- Location: Derabassi, Punjab
- Salary: Best in industry (Negotiable based on expertise)
- Industry: Pharmaceutical / API Manufacturing
This DRA API job in Punjab is ideal for regulatory professionals with hands-on experience in Active Pharmaceutical Ingredients (API) dossiers and submissions.
Key Responsibilities – DRA (API)
Candidates applying for this Regulatory Affairs API job will be responsible for:
- Preparation, review, and submission of API regulatory dossiers (DMF, CEP, CTD formats).
- Managing global regulatory compliance requirements.
- Handling deficiency responses from regulatory authorities.
- Coordination with QA, QC, Production, and R&D teams.
- Lifecycle management of API documentation.
- Ensuring alignment with USFDA, EU, WHO, and other international guidelines.
This role demands strategic thinking and deep understanding of API documentation processes and international regulatory standards.
Qualifications & Skills Required
To qualify for this Drug Regulatory Affairs job in Punjab, candidates should have:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field.
- 4–10+ years of experience in API Regulatory Affairs.
- Strong knowledge of DMF, CTD, eCTD submissions.
- Experience handling global regulatory markets.
- Excellent documentation and communication skills.
- Ability to manage multiple regulatory projects independently.
Why Join Synthimed Labs?
- Competitive salary (best in industry).
- Growth-focused pharmaceutical environment.
- Exposure to global API regulatory markets.
- Inclusive workplace culture (female candidates encouraged).
- Career advancement in Drug Regulatory Affairs (DRA).
If you are looking for API Regulatory Affairs jobs in Punjab with long-term growth, this opportunity offers strong professional exposure.
How to Apply
Interested candidates can apply directly:
📧 Email your CV: astha.trivedi@synthimed.com
📍 Job Location: Derabassi, Punjab