Regulatory Affairs Associate

Regulatory Affairs Associate

Key Responsibilities:

• Prepare, review, and compile high-quality regulatory submissions (CTD/eCTD) for pharmaceutical products in RoW regions (e.g., LATAM, MENA, Southeast Asia, CIS). 
• Collaborate with cross-functional teams including R&D, QA, Manufacturing, and Commercial to ensure timely submission and regulatory compliance. 
• Track submission timelines, regulatory deliverables, and health authority queries using project management tools. 
• Author regulatory documents such as Module 1 forms, Module 2 summaries, and responses to health authority queries. 
• Support product lifecycle management through variations, renewals, and line extensions. 
• Assist in regulatory intelligence gathering and maintaining up-to-date knowledge of regulatory requirements in key RoW markets. 
• Provide support for regulatory activities related to OTC or consumer health products, including label reviews and local submissions. 

Qualifications:

• Bachelor’s degree or higher in Pharmacy, Life Sciences, Chemistry, or a related field. 
• 2–3 years of experience in regulatory affairs within the pharmaceutical or consumer health industry. 
• Hands-on experience with regulatory submissions in RoW markets. 
• Understanding of CTD structure, dossier compilation, and basic regulatory processes. 
• Familiarity with project management practices and tools. 
• Strong written and verbal communication skills. 
• Detail-oriented with strong organizational and time management abilities. 
• Knowledge of OTC/cosmetic regulations is an added advantage. 

Preferred Skills:

• Ability to multitask and work in a fast-paced environment. 
• Basic knowledge of CTD. ACTD, ICH guidelines and global regulatory frameworks.