Senior Specialist, Commercial Regulatory Affairs

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. 

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.

Learn about the Danaher Business System which makes everything possible.

The Sr. Specialist, Commercial Regulatory Affairs is responsible for preparation, submission and approvals for the Import license applications, renewals, and Post Approval change applications and ensure filings are following Country specific regulations and guidelines, with a focus on India, Sri Lanka and other SWA countries . This position reports to the Manager, Commercial Regulatory Affairs (SWA) and is part of the Commercial Regulatory Affairs Center of Excellence (COE) located in New Delhi, India and will be an on-site role.    

In this role, you will have the opportunity to:

• Initiate, prepare and submit product Import license applications, renewals, and Post Approval change applications and ensure filings are following Country specific regulations and guidelines, with a focus on India, Sri Lanka and other SWA countries.  Responsible for the coordination with Business Units Regulatory Affairs team in requesting documents for the applications.
• Responsible for responding to the queries raised by the Regulatory authority against the application submitted. Responsible for ensuring in meeting the project timelines.
• Provide proactive regulatory intelligence in areas of a competitive nature and stay on top of changes in agency regulations and requirements.
• Collaborate with cross functional departments to complete the process for the products that require in-country testing data for registration purposes. Provide regulatory assessments for anticipated analytical, manufacturing and packaging changes.
• Provide regulatory guidance with regards to preparation, review and approval of labeling and promotional materials as needed. Recognize potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors.

The essential requirements of the job include:

·Requires Degree in a Science / Pharmacy or related field

·At least 8- 10 years of relevant experience within the registration process in medical devices or IVD industry and have well versed understanding of Indi Medical Device Regulations 2017 and amendments.

·Experience in working in a matrix organization, international environment and experience in managing people. Good analytical and problem-solving skills as well as interpersonal skills with emphasis on diplomacy, negotiation and ability to work in a team-based setting; effective communication skills; flexibility; self-confidence, achievement-oriented with appropriate concern for quality are highly desirable qualifications.

·Experience in working in a matrix organization, international environment and experience in handling projects independently. IT literate with MS Office.

·Multitasks, prioritizes, and meets project deadlines in a timely manner. Ability to work in a self-directed manner to see issues through to completion.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s 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.

For more information, visit www.danaher.com.