Regulatory Affairs Associate Senior 5-7Yrs
- Bangalore, Karnataka
- Permanent
- Full-time
· Ensure submissions meet the global eCTD requirements and other regional formats (NeeS, paper).
· Coordinate with a cross functional team including Regulatory Affairs, CMC, Quality and Clinical team to plan submission strategy and timelines.
· Oversee and ensure timely publishing and dispatch of regulatory submissions using various publishing tools (e.g. Veeva Vault RIM, eCTDXpress, Extedo, Lorenz).
· Perform quality control checks of published submissions to ensure technical and formatting compliance.
· Should have expertise in health authority gateways for submission dispatch i.e. ESG, MHRA portal, CESP, EMA portal.
· Implement and maintain publishing SOPs, work instructions, and quality standards.
· Develop training programs and mentor junior team members.Qualifications:· Bachelor's or master's degree in Life science, regulatory affairs or related field with 8 or more years' experience in regulatory operations with significant hands-on publishing experience.
· Strong knowledge of global regulatory standards (eCTD, NeeS, paper) and regional authority expectations (FDA, EU, Health Canada etc.)
· Strong technical skills and proficiency with publishing tools (Veeva Vault RIM, ISI Toolbox, eCTDXpress, ISI Publisher, Adobe Acrobat, ISI Writer, Excel, Microsoft word, Databases).
· Strong attention to detail, organizational skills and the ability to manage multiple priorities under tight deadlines.
· Candidate must be able to work in a team-oriented, fast-paced environment.
· Demonstrated leadership, coaching or mentoring skills.
· Excellent communication and interpersonal skills.