Senior Manager – Regulatory Affairs
Location: Mumbai, India
Work Mode: On-site
Experience Required: Minimum 10 years
Salary Range: Not specified (industry standard based on experience)
Job Summary
Abbott is hiring a highly skilled Senior Manager – Regulatory Affairs to lead strategic and operational regulatory activities for India and global markets. The role involves regulatory submissions, lifecycle management, risk mitigation, compliance, and agency interactions. This is a critical opportunity for seasoned professionals aiming to impact regulatory strategy and product registration in a global pharmaceutical organization.
Key Responsibilities
Lead complex product registrations and submissions for new product launches.
Develop regulatory strategies across the product lifecycle.
Prepare and respond to regulatory deficiency letters.
Act as the regulatory lead in cross-functional meetings and global communications.
Manage change requests, risk mitigation, and compliance actions.
Conduct health authority interactions and coordinate with global affiliates.
Identify and implement regulatory process improvements.
Provide expert support in licensing reviews and due diligence.
Maintain up-to-date expertise on global regulatory guidelines and product requirements.
Required Skills & Qualifications
Bachelor's Degree in Pharmacy, Biology, Chemistry, Pharmacology, or related field.
Minimum 10 years of experience in Regulatory Affairs, R&D, or Manufacturing.
Strong knowledge of global regulatory requirements and local legislation.
Expertise in dossier preparation, lifecycle management, and change control.
Proven leadership and decision-making skills in high-impact regulatory functions.
Excellent communication and stakeholder management skills.
Ability to mentor and guide junior staff when required.
Perks & Benefits
Competitive industry-aligned compensation
Exposure to global regulatory frameworks and multinational collaboration
Access to leadership and professional development programs
Work with cutting-edge pharmaceutical technologies
Stable and inclusive workplace culture focused on integrity and innovation
About the Company
Abbott is a global healthcare and pharmaceutical leader, known for delivering innovative diagnostics, medical devices, nutrition, and branded generic medicines. With a legacy of over 130 years and a strong presence in India, Abbott continues to transform lives through science-based healthcare solutions.
Job Type
Full-time | On-site | Senior-Level
Call to Action
Are you ready to lead global regulatory strategy and drive product approvals at one of the world’s top healthcare companies? Apply now and bring your regulatory expertise to Abbott in Mumbai.
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