About the Role:

• We are seeking a Regulatory Affairs Specialist to join our team. The ideal candidate will be responsible for coordinating and preparing document packages for regulatory submissions, internal audits, and inspections.
• This role will involve reviewing manufacturing and design changes, communicating changes to regional Regulatory Affairs, and documenting regulatory assessments for changes.
• The Regulatory Affairs Specialist will also lead or compile all materials required for submissions, license renewals, and annual registrations.

Responsibilities: -

• Direct or perform coordination and preparation of document packages for regulatory submissions, internal audits, and inspections
• Review manufacturing and design changes, communicate changes to regional Regulatory Affairs, and document regulatory assessments for changes
• Lead or compile all materials required for submissions, license renewals, and annual registrations
• Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance
• Monitor and improve tracking/control systems
• Keep abreast of regulatory procedures and changes
• Direct interaction with regulatory agencies on defined matters
• Recommend strategies for earliest possible approvals of clinical trials applications

Education Qualification: -

• University Degree

Required Skills: -

• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
• Advanced knowledge of regulatory affairs
• Experience in coordinating regulatory submissions
• Strong communication skills
• Ability to work independently and under limited supervision
• Knowledge of project management
• Ability to mentor colleagues and direct the work of other professionals