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Regulatory Affairs Manager
3 days ago
MAIN PURPOSE OF ROLE
- Specialist professional individual contributor with comprehensive knowledge in the area of Regulatory Affairs.
- Ability to execute highly complex or specialized projects.
- Adapts precedent and may make significant departures from traditional approaches to develop solutions.
MAIN RESPONSIBILITIES
- As the Specialist in the Regulatory Affairs Sub-Function, considered as highly experienced and knowledgeable resource within the organization in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
- Interacts with regulatory agency to expedite approval of pending registration.
- Serves as regulatory liaison throughout product lifecycle.
- Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
- Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
- Serves as regulatory representative to marketing, research teams and regulatory agencies.
- Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
QUALIFICATIONS
Education
- Associates Degree (± 13 years)
Experience/Background
- Minimum 7 years
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