Specialist- Commercial Regulatory Affairs

Danaher Corporation; New Delhi; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Beckman Coulter Life Sciences, a Danaher operating company, is seeking a Senior Regulatory Affairs specialist for the Delhi/NCR on-site team. The role focuses on preparation, submission, and approvals of import licenses, renewals, and post-approval changes for India and SWA markets.

You will coordinate with cross-functional teams, respond to regulatory queries, and provide guidance on labeling and regulatory compliance to ensure timely registrations and product approvals.

Qualifications

• Requires Degree in a Science / Pharmacy or related field.
• 7-8 years of relevant experience in the registration process for medical devices or IVD industry with understanding of India Medical Device Regulations 2017 and amendments.
• Experience in working in a matrix organization and international environment; strong analytical and interpersonal skills.
• IT literate with MS Office.

Responsibilities

• Initiate, prepare and submit product Import license applications, renewals, and Post Approval change applications and ensure filings follow country regulations; focus on India, Sri Lanka and SWA countries.
• Respond to regulatory authority queries and meet project timelines.
• Collaborate with cross-functional teams to gather in-country testing data for registration and provide regulatory assessments for changes.
• Provide regulatory guidance on labeling and promotional materials and identify potential regulatory risks.

Skills

Regulatory affairs

Stakeholder collaboration

Analytical skills

Project management

Education

Science/Pharmacy degree

Tools

MS Office

Job description

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 Life Sciences, one of Danaher’s (https://danaher.com/our-businesses) 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.

At Beckman Coulter Life Sciences, we know time is the most critical facet in the laboratory today: time to get life-saving therapies to patients faster; reclaiming time by automating tedious manual workflows; and saving time spent addressing erroneous or complex results.

We are partners in time and accelerate answers to critical questions through the power of automation. We develop innovations for scientists by scientists, with many of our 3,300+ global colleagues coming from the laboratory.

It’s all part of our time-tested approach to bringing meaningful innovations at the speed of life since 1935. And we’re just beginning. Working together, let’s put our time and talents together to advance human health for tomorrow.

Learn about the Danaher Business Syste m which makes everything possible.

The 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 Delhi/NCR 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 timely responding to the queries raised by the Regulatory authority regarding the application submitted. Responsible for ensuring in meeting the project timelines.

• 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 7-8 years of relevant experience within the registration process in medical devices or IVD industry and have well versed understanding of India Medical Device Regulations 2017 and amendments.

• Experience in working in a matrix organization and international environment. 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 handling projects with minimum supervision. 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 completion.

  Beckman Coulter Life Sciences, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) .

  For more information, visit www.danaher.com .