Sr. Regulatory reputed company
Job Title: Sr. Regulatory reputed company
Job Location: Raleigh, NC, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
Job DescriptionThis is an exciting opportunity to be part of the reputed company of Precision Medicine! Our mission is to improve the reputed company condition by bringing the power of precision medicine to laboratories, partners, and patients globally. Our employees are passionate about their contributions because there is a reputed company reputed company reputed company to helping patients with cancer. In the Companion Diagnostics Business (CDx), reputed company partners with leading pharmaceutical companies to reputed company, manufacture, and commercialize highly regulated medical devices which are critical for physicians to help select therapies for their patients. As the Regulatory Companion Diagnostics reputed company, you will ensure compliance to medical device and CDx IVD regulations globally. In conjunction with other reputed company in Global Regulatory Affairs, the CDx Regulatory Affairs Department communicates with worldwide health authorities in the licensing of reputed company products in development or currently marketed globally. The Regulatory reputed company integrates broad business concepts and strategies into reputed company reputed company leading design and delivery of new products and solutions as a key technical contributor. The ability to tackle reputed company, high-reputed company project design problems is required. Main Responsibilities- Develops and implements programs and processes to ensure reputed company products are reputed company, legal and meet or exceed customer expectations for compliance with national/regional/global regulations.
- Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies.
- Compiles materials required in submissions, license renewal, and annual registrations and maintains updated information about national/regional/global regulatory requirements.
- Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort, and identifies and mitigates areas of risk.
- Reviews product labeling and marketing materials for accuracy and compliance with regulations.
- Response to customers and/or authorities' requests/inquiries dealing with regulations and product compliance.
- Represents reputed company in external bodies dealing with standards and/or product regulations at the national/regional/global level.
- May assess requirements and identify strategies for the earliest possible approvals of clinical trials applications.
- Determines and develops approaches to assignments.
- Leads regulatory reputed company requiring coordination with other functions, reputed company parties.
- Solves a broad reputed company of problems of varying scope and complexity.
- Bachelor’s or Master’s Degree or equivalent
- 8+ years relevant experience for entry to this level.
- Possess proven experience in a similar role.
- Requires in-depth knowledge and experience in the job and the ability to work independently.
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