Job Title: Senior Regulatory Affairs Manager – India & SAARC
Location: Gurgaon, India
Department: Regulatory Affairs
Experience Required: Minimum 7 years
Job Summary
Join a leading pharmaceutical company as a Senior Regulatory Affairs Manager based in Gurgaon. This strategic role will lead the regulatory affairs operations for India and the SAARC region, ensuring timely approvals of drug registrations, life cycle submissions, and regional compliance. The position demands deep expertise in regulatory frameworks, regulatory strategy, and CMC (Chemistry, Manufacturing, and Controls) processes.
Key Responsibilities
Lead development and submission of product registrations, supplements, and regulatory progress reports for India & SAARC markets.
Serve as the regulatory liaison for health authorities, expediting approvals and maintaining compliance.
Advise internal teams on regulatory strategies across product lifecycle, including manufacturing changes and technical labeling.
Ensure on-time approvals for new pharmaceuticals, biologics, and medical devices.
Collaborate with research, development, and marketing teams to ensure alignment with local regulatory guidelines.
Oversee risk management and CMC documentation relevant to regulatory submissions.
Provide interpretation and guidance on evolving regulatory requirements.
Required Skills & Qualifications
Associate Degree or higher in Life Sciences, Pharmacy, Regulatory Affairs, or related field.
Minimum 7 years of hands-on experience in pharmaceutical or healthcare regulatory affairs.
Strong understanding of India & SAARC region regulatory environments.
Experience with CMC, product life cycle management, and regulatory authority interactions.
Expertise in managing complex submissions and expediting product approvals.
Excellent communication and cross-functional collaboration skills.
Perks & Benefits
Competitive salary and performance-based bonuses
Strategic exposure across India & SAARC regulatory operations
Opportunity to work with cross-functional global teams
Learning and development opportunities
Comprehensive healthcare and wellness benefits
Inclusive work environment with leadership visibility
Company Description
Join a global pharmaceutical leader with a legacy of excellence in regulatory compliance, innovative medicines, and patient-first solutions. With a strong presence across emerging markets, the company is committed to high standards in product quality, patient safety, and ethical compliance.
Work Mode: On-site (Gurgaon, India)
Call to Action
Are you an experienced regulatory expert ready to shape drug approvals across India & SAARC? Apply now to lead impactful submissions and strategic compliance at a global healthcare innovator.
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