Sr. Regulatory Affairs

Why This Role Matters

In the pharmaceutical industry, regulatory compliance is critical to ensure that products are safe, effective, and legally marketable across global markets. Regulatory Affairs Managers act as the bridge between development teams and regulatory authorities, ensuring that all documentation, approvals, and submissions adhere to national and international standards. Non-compliance or delayed submissions can result in product launch delays, regulatory actions, or reputational risk.
This role is pivotal in maintaining compliance throughout a product’s lifecycle from development and clinical trials to post-marketing surveillance—ensuring timely approvals and alignment with evolving regulatory guidelines. By managing submissions, approvals, and documentation, the Regulatory Affairs Manager supports product quality, market access, and overall business success.

Job Description

We are seeking a detail-oriented and highly skilled Regulatory Affairs Manager – Pharmaceuticals to oversee regulatory documentation, submissions, and compliance activities. The role focuses on preparing high-quality regulatory dossiers, liaising with health authorities, and ensuring that pharmaceutical products meet global regulatory standards. The candidate will collaborate with cross-functional teams such as R&D, QA/QC, Medical Affairs, and Manufacturing to ensure regulatory readiness and compliance across all stages of the product lifecycle.
This is a full-time position based in New Delhi, India, reporting to the Managing Director/Manager Operations.

Key Features of the Role

• Full ownership of regulatory submissions and approvals
• Cross-functional collaboration across R&D, QA/QC, and Manufacturing
• Exposure to global regulatory frameworks including FDA, EMA, ICH, CDSCO
• Strategic involvement in regulatory risk assessments and lifecycle management
• Oversight of labeling, packaging, and promotional compliance
• Active role in clinical trial applications and post-marketing surveillance

Responsibilities

• Approve labels, packaging, and promotional materials (leaflets, websites, social media) for compliance under FSSR and other export market rules as per applicable guidelines
• Summarize scientific and technical data for regulatory submissions
• Prepare, compile, and submit regulatory dossiers for new product approvals, renewals, and variations
• Ensure timely submissions to regulatory agencies
• Manage communication and correspondence with health authorities
• Track and interpret changes in pharmaceutical regulations and provide guidance to internal stakeholders
• Review and approve product labeling, packaging, and promotional materials for regulatory compliance
• Support clinical trials by submitting and maintaining INDs or clinical trial applications (CTA)
• Maintain regulatory databases and documentation for inspections and audits
• Liaise with cross-functional teams (R&D, QA/QC, Medical Affairs, Manufacturing) to ensure compliance and regulatory readiness
• Contribute to regulatory strategy and risk assessments during drug development and post-marketing phases

Required Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or related field
• 5–8 years of experience in pharmaceutical regulatory affairs
• Strong knowledge of global regulatory requirements (FDA, EMA, ICH, CDSCO, etc.)
• Attention to detail, critical thinking, and organizational skills
• Excellent written and verbal communication skills

Preferred Qualifications

• Regulatory Affairs Certification (RAC) or equivalent is a plus
• Familiarity with global submission platforms (e.g., ESG, CESP, EU Portal)
• Experience in new drug applications (NDA), abbreviated NDAs (ANDA), and post-marketing surveillance

Educational Requirements

• Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline
• Candidates with a strong academic foundation in pharmaceutical sciences and interest in regulatory affairs are encouraged to apply

Experience and Skills

• 5–8 years of relevant experience in pharmaceutical regulatory affairs
• Experience in preparing regulatory dossiers, INDs, CTAs, NDAs, and ANDAs
• Exposure to global regulatory submission platforms
• Strong knowledge of compliance standards across multiple jurisdictions
• Ability to manage multiple submissions and timelines effectively
• Excellent documentation, analytical, and problem-solving skills
• Strong stakeholder management and cross-functional coordination abilities
• Proactive approach to monitoring regulatory changes and implementing updates

Salary Insights

• Compensation: ₹30,000 – ₹50,000 per month
• Salary aligned with industry standards for Regulatory Affairs Managers in India
• Additional benefits include cell phone reimbursement, health benefits, and performance incentives

Company Overview

The organization is a pharmaceutical company committed to innovation, compliance, and global product accessibility. With a strong focus on regulatory excellence, the company ensures that all products meet national and international standards, supporting patient safety and business growth. The company culture emphasizes teamwork, professional development, and adherence to ethical and regulatory practices.

FAQs

1. Is prior experience in regulatory affairs mandatory?
   Yes, 5–8 years of experience in pharmaceutical regulatory affairs is required.

2. Does this role involve cross-functional coordination?
   Yes, the position requires regular collaboration with R&D, QA/QC, Medical Affairs, and Manufacturing teams.

3. Are global regulatory frameworks relevant?
   Yes, strong knowledge of FDA, EMA, ICH, and CDSCO regulations is essential.

4. Will the role handle clinical trial applications?
   Yes, the candidate will support IND and CTA submissions for clinical trials.

5. Is approval of labeling and promotional material included?
   Yes, reviewing and approving product labeling, packaging, and promotional content is part of the role.

Application Tips

• Highlight regulatory submission experience (NDAs, ANDAs, INDs, CTAs)
• Emphasize global regulatory knowledge and compliance exposure
• Mention experience with labeling, packaging, and promotional approvals
• Showcase cross-functional collaboration and communication skills
• Provide examples of managing submission timelines and inspections