Urgent Hiring || Regulatory Affairs Specialist || Mumbai Location || Designation : Regulatory Affairs Specialist

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

Experience:
Minimum 2-5 years of experience in regulatory affairs

Salary:
5 lpa

Location:
Sandhurst Road Mumbai
- Head office 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 positive knowledge of Regulatory Submissions
- Must have good knowledge of Regulatory Research
- Must be familiar with chemical industry-specific regulations and guidelines.

📌 Regulatory Affairs Specialist (Mumbai)
🏢 orbiTouch HR (orbiTouch outsourcing
📍 Mumbai