Regulatory Affairs Manager

Job Summary:
The Regulatory Affairs Manager is responsible for ensuring that the company’s products comply with all applicable regulatory requirements and standards. This role manages regulatory submissions, liaises with regulatory authorities, and provides regulatory guidance across departments to support product development, approval, and lifecycle management.

Key Responsibilities:

• Develop and implement regulatory strategies for product development, registration, and commercialization.
• Prepare, review, and submit regulatory documents to local and international regulatory authorities.
• Ensure compliance with applicable regulations, guidelines, and standards.
• Act as the primary point of contact with regulatory agencies and respond to inquiries in a timely manner.
• Monitor changes in regulatory requirements and assess their impact on products and business operations.
• Provide regulatory guidance to cross-functional teams including R&D, Quality, Manufacturing, and Marketing.
• Support audits, inspections, and regulatory reviews.
• Maintain regulatory documentation and ensure accurate record-keeping.
• Train internal teams on regulatory requirements and compliance best practices.

Qualifications & Skills:

• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related field (Master’s preferred).
• Proven experience in regulatory affairs within a regulated industry (e.g., pharmaceuticals, medical devices, cosmetics, food, or biotechnology).
• Strong knowledge of local and international regulatory frameworks.
• Excellent written and verbal communication skills.
• Strong attention to detail and organizational skills.
• Ability to manage multiple projects and meet deadlines.

Experience:

• Typically 5–8 years of experience in Regulatory Affairs, with leadership or managerial experience preferred.

Key Competencies:

• Regulatory compliance
• Strategic thinking
• Risk assessment
• Cross-functional collaboration
• Problem-solving

Job Type: Full-time

Pay: ₹325,873.94 - ₹1,099,836.77 per year

Benefits:

• Health insurance
• Leave encashment
• Life insurance
• Provident Fund

Work Location: In person