Regulatory Affairs Associate

Why This Role Matters
The Regulatory Affairs Associate plays a key role in preparing, reviewing, and managing regulatory dossiers to ensure compliance with global regulations. By handling CTD dossiers, process and analytical method validations, and responding to queries from regulatory authorities, this role supports timely product approvals and contributes to the overall success of the organization. The position ensures high-quality submissions, regulatory compliance, and smooth communication with authorities, enabling Apex Drug House to bring safe and effective products to market.

Job Description
The Regulatory Affairs Associate is responsible for preparing and reviewing regulatory dossiers, managing process validation and analytical method validation documents, and addressing queries from regulatory bodies. The role requires close collaboration with cross-functional teams, attention to detail, and thorough knowledge of regulatory requirements to ensure accurate and timely submissions. The position supports both local and international regulatory submissions, contributing to Apex Drug House’s mission of delivering high-quality pharmaceutical products.

Key Features Of The Role
• Prepare and review CTD dossiers for regulatory submissions
• Review and evaluate process validation and analytical method validation documents
• Handle queries and responses from different regulatory authorities
• Ensure submissions comply with applicable regulations and agency guidelines
• Maintain up-to-date knowledge of regulatory requirements and industry standards
• Collaborate with cross-functional teams including Quality, Production, and R&D
• Support preparation of responses to deficiencies or additional information requests
• Maintain accurate records of all regulatory submissions and correspondence

Responsibilities
• Draft, compile, and review regulatory dossiers, ensuring accuracy and completeness
• Evaluate process validation and analytical method validation documentation
• Respond to queries from local and international regulatory authorities
• Ensure compliance with internal SOPs and global regulatory guidelines
• Support cross-functional teams with regulatory guidance during product development
• Track submission status and maintain regulatory documentation archives
• Assist in audits and regulatory inspections, providing relevant dossiers and supporting documentation
• Monitor updates to regulations and implement changes to ensure compliance
• Contribute to continuous improvement of regulatory processes and documentation standards

Required Qualifications

Educational Requirements
• Graduate or Postgraduate degree (B. Pharma / M. Pharma preferred)

Experience And Skills
• 3–7 years of experience in a regulatory affairs or similar profile
• Experience in preparation and review of CTD dossiers
• Knowledge of process validation and analytical method validation requirements
• Experience in handling regulatory queries from authorities
• Strong attention to detail, organizational, and documentation skills
• Good communication and interpersonal skills
• Ability to collaborate with cross-functional teams and meet submission timelines

Salary Insights
• Compensation as per company norms and industry standards
• Opportunities for career growth and professional development
• Exposure to regulatory submissions and interactions with local and international authorities

Company Overview
Apex Drug House is a pharmaceutical company committed to delivering high-quality medicines globally. The company focuses on regulatory compliance, innovation, and scientific rigor to ensure safe and effective products. Apex Drug House fosters a collaborative culture, providing employees opportunities to contribute to drug development and regulatory success.

FAQs
Q: What type of regulatory documents will I handle?
A: CTD dossiers, process validation reports, analytical method validation documents, and responses to regulatory queries.

Q: Will I interact with regulatory authorities?
A: Yes, the role involves addressing queries and communications with local and international authorities.

Q: Is prior regulatory experience required?
A: Yes, 3–7 years of experience in a regulatory affairs or similar role is required.

Application Tips
• Highlight experience in CTD dossier preparation and review
• Emphasize knowledge of process validation and analytical method validation
• Showcase experience handling regulatory queries
• Demonstrate strong attention to detail and ability to manage timelines
• Include examples of successful submissions or approvals