Principal Specialist, Commercial Regulatory Affairs job in New Delhi, Delhi, India

Job Description

JOB DESCRIPTION

Wondering whats within Beckman Coulter Diagnostics? Take a closer look.

At first glance, youll see that for more than 80 years weve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. Were building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and youll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, were working at the pace of change to improve patient lives with diagnostic tools that address the worlds biggest health challenges.

The Principal Specialist defines and executes regulatory strategies to support business objectives in a dynamic regulatory environment. This role ensures seamless execution of regulatory plans, compliance with internal and external requirements, and fosters strong partnerships with regulatory authorities. The incumbent acts as a trusted advisor to business stakeholders, guiding product registrations, lifecycle management, and post-market compliance, while representing the organization in external forums. This position is part of the Regulatory Affairs located in New Delhi and will be on-site. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the Quality Assurance and Regulatory Affairs team and report to the Manager- Regulatory Affairs. If you thrive in an amazing, multi country, multifunctional, multidomain role and want to work to build a world-class Quality Assurance and Regulatory Affairs organizationread on.

Key Responsibilities 1. Regulatory Strategy & Execution

• Develop robust RA strategies and plans based on regulatory and business landscape.
• Ensure compliance with applicable local and regional regulatory requirements for India & SWA.
• Support business continuity and new growth opportunities through timely product registrations and renewals.

2. Product Registration & Lifecycle Management

• Lead and manage timely submissions for new product registrations, renewals, post-approval changes, and lifecycle maintenance activities.
• Coordinate with manufacturers/legal manufacturers and cross-functional teams to ensure 100 PERCENT on-time submissions in line with KPIs and metrics.
• Conduct impact assessments for regulatory changes and present findings to the Global Regulatory Council.

3. Compliance & Post-Market Activities

• Oversee post-market regulatory activities, including vigilance, reporting, and regulatory inspections.
• Review and approve promotional/marketing materials for compliance with applicable regulations.
• Represent the organization during audits and inspections related to regulatory processes.

4. Regulatory Intelligence & Advocacy

• Monitor and communicate regulatory landscape changes, providing timely intelligence and actionable insights.
• Engage with regulatory authorities, trade associations, third-party organizations, and government bodies to influence policies and guidelines.
• Represent the company in external forums to shape regulatory frameworks.

5. Collaboration & Continuous Improvement

• Partner with global, regional, and local teams to ensure regulatory alignment and knowledge sharing.
• Provide training and guidance on regulatory requirements and processes to local staff.
• Contribute to the development and improvement of local regulatory procedures, SOPs, and work instructions.
• Drive harmonization of best practices across regions.

Job Requirements

• Bachelors degree in science / pharmacy or related field with 10 years of experience within the medical devices or IVD industry OR Masters degree in field with 7 years of experience OR Doctoral degree in field with 5 years of experience.
• In-depth knowledge of Indian and SWA regulatory requirements.
• Experience in working in a matrix organization & International environment.

Join our winning team today. Together, well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

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