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 : good hike on current salary
Location : Lower Parel, Mumbai
Job Summary:
We are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements for our products, managing the submission process for regulatory approvals, and maintaining up-to-date knowledge of regulatory changes.
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:
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 degree in a scientific discipline, such as pharmacy, biology, or chemistry?
- Do you have work experience in API Pharma?
- Are you available for the f2f interview?
Experience:
- Regulatory Compliance: 4 years (Required)
- Regulatory Documentation: 4 years (Required)
- Audits and Inspections: 4 years (Required)
Work Location: In person
