Regulatory Affairs Associate

Why This Role Matters
• The Regulatory Affairs Associate is vital to ensuring regulatory compliance for pharmaceutical and clinical research products by managing safety reporting and global regulatory documentation.
• This role helps maintain adherence to international regulatory guidelines, ensuring the safety and efficacy of products through accurate reporting and timely submissions.

Job Description
• As a Regulatory Affairs Associate, you will be responsible for preparing and managing regulatory submissions, including Individual Case Safety Reports (ICSRs), Aggregate Reports, CCDS, USPI, SmPC, and other safety-related documents.
• You will coordinate with Health Authorities and support regulatory activities related to Clinical Trials to ensure full compliance with global regulatory requirements.

Key Features of the Role:
• Full-time, remote role based in Bengaluru, Karnataka
• Focus on regulatory submissions, safety reports, and global compliance
• Involvement in coordinating regulatory communications with Health Authorities
• Ensures timely and accurate preparation of safety-related documents

Responsibilities
• Manage and prepare regulatory submissions, including ICSRs, Aggregate Reports, CCDS, USPI, SmPC
• Compile and submit monthly Regulatory Intelligence reports
• Coordinate and manage regulatory communications with Health Authorities
• Support Regulatory Affairs activities related to Clinical Trial (CT) processes
• Ensure compliance with global regulatory guidelines and submission standards

Required Qualifications
• 3–5 years of experience in Regulatory Affairs within the pharmaceutical or clinical research industry

Educational Requirements:
• Degree in Pharmacy, Life Sciences, or related field (preferred but not specified)

Experience and Skills:
• 3–5 years of relevant experience in Regulatory Affairs
• Hands-on experience in global regulatory submissions and documentation
• Strong understanding of international regulatory guidelines and submission processes
• Good communication, coordination, and documentation skills

Age Eligibility:
• No specific age criteria mentioned

Salary Insights
• Competitive salary (not disclosed)

Company Overview
• Synapmed is a leading organization in the healthcare and pharmaceutical industry, providing regulatory services and solutions to ensure product compliance and safety. With a strong focus on safety reporting and regulatory submissions, Synapmed supports global healthcare companies in maintaining regulatory standards.

FAQs
1 Is prior experience in regulatory submissions required?
Yes, candidates must have 3–5 years of experience in this field.
2 Does the role require shift work?
No, this is a full-time, remote position with no specific shift requirements.

Application Tips
• Tailor your resume to highlight relevant regulatory experience, especially in safety reporting and global submissions.
• Emphasize your communication and coordination skills, as they are critical for working with regulatory bodies.