- Full Time
- New Delhi India
Website Beckman Coulter
Table of Contents
ToggleAbout Beckman Coulter
Elevating Patient Health for Over 80 Years
Beckman Coulter Diagnostics, a global leader in clinical diagnostics, has been challenging conventions for more than 80 years to elevate the role of diagnostic laboratories in improving patient health. Our mission is to relentlessly reimagine healthcare, one diagnosis at a time. We achieve this by harnessing the power of science and technology, combined with the passion and creativity of our teams.
Our Diagnostic Solutions
Our diagnostic solutions are designed for complex clinical testing and are utilized in hospitals, reference laboratories, and physician office settings around the world. We are committed to delivering smarter, faster diagnostic solutions that drive progress from what’s now to what’s next. We accelerate care through an extensive clinical menu, scalable lab automation technologies, insightful clinical informatics, and optimized lab performance services.
Global Presence and Expertise
Headquartered in Brea, California, Beckman Coulter Diagnostics boasts over 11,000 global team members and is proud to be part of Danaher. Danaher’s leadership in science and technology places our solutions at the forefront of the industry, enabling us to reach more people and make a greater impact.
Collaboration with Danaher
As part of Danaher, we offer unparalleled expertise and solutions to our customers. Together with Danaher’s other businesses in Biotechnology, Diagnostics, and Life Sciences, we unlock the transformative potential of cutting-edge science and technology to improve billions of lives every day.
Job Description
The Sr. Specialist in Regulatory Affairs will independently manage and prepare regulatory submissions with minimal supervision. This role involves engaging with Business Units’ Regulatory Affairs teams and interacting with regulatory agencies/health authorities to secure and maintain product approvals, focusing on India, Sri Lanka, and other South West Asia (SWA) countries, in accordance with local regulations. Responsibilities also include initiating document requests from Business Unit Regulatory Affairs teams and submitting these to Indian regulatory authorities for any post-approval changes to products approved in India. The specialist will ensure compliance with local and regional regulatory requirements in India and the SWA region.
Key Responsibilities
- Product Licensing: Initiate, prepare, and submit product import license applications, renewals, and post-approval change applications, ensuring filings comply with country-specific regulations and guidelines, with an emphasis on India, Sri Lanka, and other SWA countries.
- Coordination: Collaborate with Business Units’ Regulatory Affairs teams to request necessary documents for applications.
- Regulatory Queries: Address queries from regulatory authorities regarding submitted applications.
- Project Timelines: Ensure adherence to project timelines.
- Regulatory Intelligence: Stay informed about changes in agency regulations and competitive regulatory intelligence.
- Cross-Functional Collaboration: Work with cross-functional departments to facilitate in-country testing data for registration purposes.
- Regulatory Assessments: Provide regulatory assessments for anticipated changes in analytical, manufacturing, and packaging processes.
- Compliance Management: Manage regulatory stop-ship orders for products registered and newly registered in India.
- Guidance and Approval: Offer regulatory guidance for the preparation, review, and approval of labeling and promotional materials as needed.
- Problem Identification: Proactively identify potential problems, including ambiguous situations, by analyzing internal and external factors.
- Reporting: Prepare formal written reports, PowerPoint presentations, and documents for distribution within the work unit and regions.
- Corrective Actions: Assess and implement corrective actions to prevent recurrence.
- Database Maintenance: Maintain local and global registration databases.
Candidate Profile
- Educational Qualification: Degree in a science/pharmacy or related field.
- Experience: At least 8-10 years of relevant experience in the registration process within the medical devices or in vitro diagnostics (IVD) industry.
- Regulatory Knowledge: In-depth knowledge of regulatory requirements in India and other jurisdictions.
- International Experience: Experience working in a matrix organization and international environment, with people management skills.
- Skills:
- Strong analytical and problem-solving abilities.
- Excellent interpersonal skills with a focus on diplomacy, negotiation, and teamwork.
- Effective communication skills, flexibility, self-confidence, and achievement orientation.
- Strong concern for quality.
- Adaptability: Ability to work under time pressure and independently within a team.
- Customer Focus: Strong interest in customer satisfaction.
- IT Proficiency: Proficiency in MS Office.
- Multitasking: Ability to prioritize tasks and meet project deadlines timely.
- Self-Directed: Ability to work independently to resolve issues to completion.
Additional Information
- Experience: 8-10 years
- Qualification: Degree in a science/pharmacy field
- Location: New Delhi, India
- Industry Type: Pharma
- Functional Area: Quality & Regulatory Affairs
- Application End Date: 10th July 2024
If you meet the qualifications and are interested in this exciting opportunity, we encourage you to apply before the application end date. Join us in simplifying, automating, and innovating biomedical testing processes in a dynamic and supportive environment.
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