Regulatory Manager - Renewable Energy Sector Only

Job Description – Regulatory Manager

Job Title: Regulatory Manager

Department: Regulatory Affairs

Experience: 8–25 Years

Location: Hyderabad

Employment Type: Full-Time

Job Summary

Seeking an experienced Regulatory Manager to lead regulatory compliance activities, obtain and maintain product approvals, and ensure compliance with applicable national and international regulations. The role requires close collaboration with R&D, Quality, Manufacturing, Supply Chain, and Commercial teams to support timely product launches and ongoing regulatory compliance.

Key Responsibilities

· Develop and execute regulatory strategies for new and existing products.

· Prepare, review, and submit regulatory dossiers, registrations, licenses, and renewals.

· Monitor changes in regulatory requirements and assess business impact.

· Coordinate with government authorities, certification bodies, and external consultants.

· Ensure compliance with applicable standards, guidelines, and regulatory frameworks.

· Support product launches by obtaining necessary regulatory approvals on time.

· Maintain regulatory documentation and compliance records.

· Partner with Quality, Manufacturing, R&D, and Supply Chain teams to resolve regulatory issues.

· Support internal and external audits and regulatory inspections.

· Provide regulatory guidance and training to internal stakeholders.

· Drive continuous improvement in regulatory processes and documentation.

Required Qualifications

· Bachelor's degree in Pharmacy, Life Sciences, Engineering, Chemistry, Biotechnology, or a related discipline (Master's preferred).

· 8–25 years of regulatory affairs/compliance experience.

· Strong knowledge of applicable regulatory requirements and submission processes.

· Experience managing regulatory submissions and product registrations.

· Excellent documentation, communication, and stakeholder management skills.

· Experience with audits, inspections, and compliance programs.

Preferred Skills

· Regulatory strategy

· Technical documentation

· Risk assessment

· Regulatory intelligence

· Project management

· SAP/ERP knowledge (preferred)

· MS Office proficiency

Key Competencies

· Leadership

· Analytical thinking

· Problem-solving

· Attention to detail

· Negotiation

· Cross-functional collaboration

· Time management