MAIN PURPOSE OF THE ROLE
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.
MAIN RESPONSIBILITIES
• 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.
QUALIFICATIONS
Education
Education Level Major/Field of Study or Equivalent
Associates Degree (± 13 years)
Experience/Background
Experience Experience Details
Minimum 1 year
Licenses and Certifications
Language Proficiency
Language Proficiency
The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.
Based on 3,330 disclosed Healthcare salaries on RoleSuite, the role pays a median of $112K/year, with most offers between $87K and $167K (10th–90th percentile: $66K–$252K).
See the full Healthcare salary breakdown →