Executive / Senior Executive - Regulatory Affairs

Why This Role Matters
The Executive / Senior Executive – Regulatory Affairs role plays a critical part in ensuring medical device products meet national and international regulatory standards. The position supports regulatory documentation, compliance with global guidelines, and quality assurance processes to ensure safe and effective healthcare products reach the market.

Job Description
This role involves managing regulatory documentation, preparing Technical Case Files (TCF), supporting regulatory submissions, and ensuring compliance with global regulatory standards. The candidate will work closely with quality, manufacturing, and clinical teams to maintain regulatory documentation and support regulatory audits.

Key Features of the Role
• Opportunity to work in regulatory affairs within the pharmaceutical and medical device industry
• Exposure to international regulatory frameworks and compliance standards
• Experience in regulatory documentation and submission processes
• Involvement in clinical evaluation and post-market surveillance activities
• Career growth opportunities within regulatory affairs and quality compliance

Responsibilities
• Prepare, compile, and review Technical Case Files (TCF) for medical devices
• Ensure compliance with regulatory standards including U.S. Food and Drug Administration guidelines and International Council for Harmonisation requirements
• Prepare and review artwork and labeling documentation for medical devices
• Support clinical evaluation and post-market surveillance activities
• Participate in post-market clinical follow-up (PMCF) activities
• Review regulatory technical documents such as process validation protocols and reports
• Review specifications, standard testing procedures, and certificates of analysis
• Support stability study documentation and batch manufacturing records
• Prepare and maintain standard operating procedures and regulatory documentation
• Support internal and external regulatory audits
• Perform regulatory documentation tasks assigned by the Head of Department

Required Qualifications

Educational Requirements
• Bachelor of Pharmacy (B.Pharm) OR
• Master of Pharmacy (M.Pharm)

Experience and Skills
• 0 to 5 years of experience in Regulatory Affairs
• Experience in medical device regulatory documentation preferred
• Knowledge of regulatory frameworks and documentation practices
• Familiarity with global regulatory standards and compliance requirements
• Strong documentation and analytical skills
• Ability to work collaboratively with cross-functional teams

Key Skills
• Regulatory affairs documentation and compliance
• Technical Case File preparation
• Regulatory submission support
• Standard operating procedure documentation
• Quality and audit support
• Knowledge of ICH guidelines and regulatory frameworks

Salary Insights
• Estimated Salary: INR 2.5 LPA – INR 4 LPA

Company Overview
Zuche Pharmaceuticals operates in the pharmaceutical and medical device sector, focusing on regulatory compliance, quality systems, and healthcare product development. The organisation supports regulatory processes aligned with international standards, ensuring that medical devices and healthcare products meet strict safety and compliance requirements.

FAQs
• What qualifications are required for this role?
Candidates must hold a B.Pharm or M.Pharm degree.

• Is experience mandatory?
Candidates with 0–5 years of regulatory affairs experience can apply.

• What regulatory standards are involved in this role?
The role involves working with international regulatory guidelines including USFDA and ICH frameworks.

• What is the salary range for this position?
The estimated salary ranges from INR 2.5 LPA to INR 4 LPA.

Application Tips
• Highlight regulatory affairs experience in your resume
• Mention experience with technical documentation and regulatory submissions
• Include knowledge of international regulatory guidelines if applicable
• Emphasise experience with SOPs and regulatory compliance processes
• Ensure your application includes all educational and experience documentation