Urgent Hiring || Regulatory Affairs Specialist || Lower Parel, Mumbai

Designation : Regulatory Affairs Specialist

Qualifications: Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry

Experience : Minimum 4 years of experience in regulatory affairs

Salary : valuable hike on current salary

Location : Lower Parel, Mumbai

Job Summary:
Essential Duties and Responsibilities:
- Regulatory Compliance: Ensure company products comply with relevant regulatory requirements, such as USFDA, FDA, EMA, and local regulations.
- Submission Management: Prepare and submit regulatory documents, such as INDs, NDAs, and MAAs, to regulatory agencies.
- Regulatory Strategy: Develop and implement regulatory strategies to support product development and commercialization.
- Regulatory Intelligence: Stay up-to-date with changing regulatory requirements and provide guidance to internal stakeholders.
- Audits and Inspections: Coordinate and manage regulatory audits and inspections.
- Labeling and Advertising:



Review and approve product labeling and advertising materials for regulatory compliance.
- Regulatory Agency Interactions: Communicate with regulatory agencies, such as the FDA, to address questions and concerns.
- Regulatory Documentation: Maintain and manage regulatory documents, such as regulatory submissions, approvals, and correspondence.
- Training and Guidance: Provide regulatory training and guidance to internal stakeholders.
- Compliance Monitoring: Monitor company activities for compliance with regulatory requirements.

Skills:
- Must have good knowledge of Regulatory Submissions
- Must have good understanding of Regulatory Research
- Must be familiar with chemical industry-specific regulations and guidelines.

Pay: ₹500,000.00 - ₹700,000.00 per year

Benefits:
- Provident Fund

Application Question(s):
- How many Years of experience in Regulatory Strategy?
- What is your current ctc?
- what is your expected ctc?
- Have yuo qualified Bachelor's d

📌 Regulatory Affairs Specialist (Lower Parel)
🏢 Orbitouch Outsourcing Private
📍 Lower Parel