Regulatory Affairs Officer/ Sr Officer Hiring at BDR Pharmaceuticals | Apply Now
- Current Vacancy: Regulatory Affairs Officer/ Sr Officer
- Key Responsibilities
- Required Skills and Expertise
- Why Join BDR Pharmaceuticals?
- How to Apply
BDR Pharmaceuticals, a leader in the pharmaceutical industry, is seeking talented professionals to join their Regulatory Affairs (RA) team. This exciting opportunity is ideal for individuals with a strong background in regulatory compliance and a passion for ensuring product quality and market readiness. Located in Luna, Padra, this position offers career growth in a dynamic and innovative environment.
Current Vacancy: Regulatory Affairs Officer/ Sr Officer
Job Details:
- Department: Regulatory Affairs (RA)
- Designation: Officer/ Sr. Officer
- Qualification: M.Pharm / B Pharm
- Experience: 2–3 years in Regulatory Affairs
- Location: Luna, Padra
Key Responsibilities
1. Compilation and Review of Drug Master Files (DMF):
- Prepare complete Drug Master Files (DMFs) for submission in global markets, including the US, EU, and Rest of World (ROW).
- Ensure that DMFs comply with regional regulatory guidelines such as USFDA, EMEA, and NMPA.
2. Regulatory Compliance:
- Review regulatory documentation to ensure alignment with ICH and other international guidelines.
- Update and maintain regulatory files based on evolving regional requirements.
3. Coordination with Teams:
- Collaborate with cross-functional teams to gather essential information for regulatory submissions.
- Liaise with regulatory authorities to address queries and ensure timely approvals.
Required Skills and Expertise
- In-depth knowledge of ICH guidelines and regional regulatory standards.
- Strong understanding of regulatory processes for pharmaceutical products.
- Attention to detail, analytical thinking, and excellent communication skills.
Why Join BDR Pharmaceuticals?
BDR Pharmaceuticals is a renowned name in the industry, known for its commitment to innovation, quality, and employee growth. Working here means:
- Being part of a company that impacts global healthcare positively.
- Gaining exposure to regulatory processes in various international markets.
- Access to professional development and training opportunities.
How to Apply
Interested candidates meeting the qualifications and experience criteria can send their updated resumes to mrunali.uttekar@bdrpharma.com with the subject line “Application for Officer/ Sr. Officer – RA.”
Application Checklist:
- Total experience details
- Current CTC/In-hand salary
- Notice period
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