Regulatory Affairs Specialist

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.

• Software:

  Good
  knowledge about regulatory software’s like, Pharmareddy, eCTD Global, Educe Solution.

• Competency:

  Thorough knowledge in filling DMF/Master files/Submissions to countries like Europe/UK, Australia, Brazil, GCC, Jordan, Switzerland, Ukraine, Tunisia, Singapore, Mexico.

• Login/Account Creation:

  Having knowledge to make Company Login/Account Creation on all Countries Regulatory Portals.

• 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.

• Document Preparation:

  having knowledge about or can solo prepare all the Regulatory applications submission data for all countries.

• 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 knowledge of Regulatory Research
• Must be familiarity with chemical industry specific regulations and guidelines.