Senior Regulatory Affairs Executive

Job description

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.