Regulatory Affairs Specialist

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