Specialist Regulatory Affairs
Job Description
MAIN PURPOSE OF ROLE
Education
- Experienced professional individual contributor that works under limited supervision.
- Applies subject matter knowledge in the area of Regulatory Affairs.
- Requires capacity to apply skills/knowledge within the context of specific needs or requirements.
- As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills 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.
Education
- Associates Degree (± 13 years)
- Minimum 1 year
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Key Skills
About Company
Skills:
chemistry manufacturing control (CMC), periodic experience reports, risk management, product plan development, technical labeling, regulatory strategy, amendments, line extensions, supplements, regulations and interpretations, progress reports, manufacturing changes, product registration submission, regulatory liaison
Skills:
regulatory strategy, regulatory liaison, Risk management, Product registration
Skills:
regulatory intelligence , Regulatory processes, Pharmacovigilance, Scientific consulting, Drug safety, Risk management