Senior Regulatory Affairs Executive

Roles and Responsibilities :

• Ensure compliance with regulatory requirements for pharmaceutical products in the European region (ROW) by preparing dossiers, submitting applications, and maintaining records.
• Collaborate with cross-functional teams to develop and implement regulatory strategies for new product launches and variations.
• Review and analyze regulatory documentation, including CTDs, eCTDs, and other submission documents to ensure accuracy and completeness.
• Provide guidance on regulatory affairs best practices to junior team members.

Job Requirements :

• 3-8 years of experience in Regulatory Affairs in the pharmaceutical industry, preferably with a focus on ROW markets.
• Strong understanding of EU regulations governing pharmaceutical products (e.g., GMP, Gxp).
• Experience working with electronic submission formats such as eCTD.
• Proven track record of successfully managing multiple projects simultaneously while meeting deadlines.