Assistant Manager – Submission Publishing

<p>MAIN PURPOSE OF THE ROLE</p><p>Experienced professional individual contributor that works under limited supervision.</p><p>Applies subject matter knowledge in the area of Regulatory Affairs.</p><p>Requires capacity to apply skills/knowledge within the context of specific needs or requirements.</p><br /><p>MAIN RESPONSIBILITIES</p><p>

• 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.</p><p>
• Interacts with regulatory agency to expedite approval of pending registration.</p><p>
• Serves as regulatory liaison throughout product lifecycle.</p><p>
• Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).</p><p>
• Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.</p><p>
• Serves as regulatory representative to marketing, research teams and regulatory agencies.</p><p>
• Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.</p><br /><p>QUALIFICATIONS</p><p>Education</p><p>Education Level Major/Field of Study or Equivalent</p><p>Associates Degree (± 13 years) </p><p>Experience/Background</p><p>Experience Experience Details</p><p>Minimum 1 year </p><br />