Regulatory Affairs Specialist - CMC/NDA/Clinicals

Responsibilities :

- Plan, prepare, and submit high-quality files to health authorities for fast approvals

- Work as an integrated part of global cross-functional teams with stakeholders from various departments

- Prepare and deliver meeting packages to Health Authorities

- Conduct Health Authority interactions and seek regulatory approvals globally

- Demonstrate subject matter expertise in regulatory science and global Life Cycle Management activities.

Key Duties:

- Compile, review, and submit pre-meeting packages for authority meetings

- Handle post-approvals, query responses, and change requests from Quality Assurance

- Submit regulatory files, respond to health authorities, and maintain marketing authorizations worldwide

- Manage Pharmacovigilance documentation, including Drug Safety Update Reports, Periodic Safety Update Reports, Investigation Brochures, Clinical Trial Reporting, and clinical trial applications

- Handle Life Cycle Management (LCM) of the product, including maintaining clinical file protocols and interim study reports

Qualifications:

- 10+ years of experience in Regulatory Affairs, specifically in CMC/NDA/Clinicals

- Graduate or postgraduate degree required

- Experience in handling health authorities, government bodies, and local market authorities

- Experience in life cycle management of products

- Global exposure in handling different markets

- Excellent communication and presentation skills

- Bold and strong personality with proven negotiation skills

- Self-managed with a strong personal drive

- Team player with the ability to engage with colleagues and peers

- High cultural sensitivity and comfortable working across different countries and time zones