Manager - Regulatory Affairs

<p><b>Primary Job Function:</b></p><p><b> </b></p><p><i><b><u>With Manager Support:-</u></b></i></p><p><b> </b></p><p><i><b>1. Product registrations / Submissions</b></i></p><p>-Actively leads product registrations by preparing/ requesting documentation needed for complex filings</p><p>-Employs project management skills to monitor activities and meet deadlines</p><p>-Prepares registration packages for routine filings</p><p>-Identifies and collects data needed</p><p>-Seeks expert advice and technical support for complex filings</p><p>-Prepares responses to deficiency letters</p><p> </p><p><i><b>2. Relationships & Cross Functional team work</b></i></p><p>-Represents Regulatory CMC at relevant project meetings and communicates agreed RA position</p><p>-Monitors and communicates actual versus planned regulatory activities and timelines</p><p>-Identifies and communicates risks and issues impacting project progression</p><p> </p><p><i><b>3. Affiliate Coordination</b></i></p><p>-Maintains strong working relationships with Regional Product Leads and Affiliate colleagues</p><p> </p><p><b>4. Compliance across Life-Cycle</b></p><p>-Assesses and approves change requests and updates files accordingly</p><p>-Maintains awareness of legislation and current developments within specific area of business</p><p>-Works to assure products remain in compliance</p><p> </p><p><i><b>5. Strategy</b></i></p><p>-Develops Regulatory CMC strategies for assigned products and projects</p><p>-Identifies, communicates, and mitigates Regulatory CMC risks</p><p><i> </i></p><p><i><b>6. Process Improvement</b></i></p><p>-Identifies opportunities and suggests improvements</p><p>-Supports the development of position papers & work aids etc</p><p> </p><p><i><b>7</b></i><b>.</b> <i><b>Health Agency Interaction</b></i></p><p>-<span style="color:#323232">Attends Health Agency meetings as appropriate</span></p><p> </p><p><i><b>8. Licensing Reviews</b></i></p><p>-Provides CMC Regulatory support for due diligence activities</p><p> </p><p><i><b>9. Technical competency</b></i></p><p>-Has general knowledge of technical/scientific principles and develops specific knowledge of allocated products</p><p>-Has general knowledge of global and regional regulatory requirements</p><p>-Has specialist regulatory knowledge of assigned country or product-class requirements</p><br /><p><b>CORE COMPETENCIES</b></p><p><b> </b></p><p><i><b>Adaptability</b></i></p><p>-Effectively prioritizes mid-term (weeks) to longer-term (months) work tasks</p><p>-Regularly reviews commitments and re-prioritises activities or negotiates timelines as necessary</p><p>-Reacts quickly to solve problems and issues when they arise</p><p> </p><p><i><b>Initiative</b></i></p><p>-Starts to learn new aspects of the business and understand the roles of other functions</p><p>-Proactively anticipates, mitigates and avoids problems and issues</p><p>-Proactively seeks feedback from manager and team members<b> </b>and adapts behaviour to improve performance</p><p> </p><p><i><b>Innovation</b></i></p><p>-Has an intrapreneurial mindset to identify new or unique ways to address work problems or opportunities</p><p> </p><p><i><b>Integrity</b></i></p><p>-Delivers high quality results.</p><p>-Meets agreed deadlines.</p><p>-Exhibits honesty and presents complete impartial information.</p><p>-Displays consistency between words and actions.</p><p>-Acknowledges and responds constructively to failures and mistakes.</p><p>-Expresses dissatisfaction constructively, without over-reacting.</p><p> </p><p><i><b>Teamwork</b></i></p><p>-Actively interacts with colleagues to drive completion of team and shared goals</p><p> </p><p><b>LEADERSHIP COMPETENCIES</b></p><p><b> </b></p><p><i><b>Set Vision and Strategy</b></i></p><p>-Clearly articulates Regulatory CMC strategies and obtains alignment and agreement from key stakeholders</p><p><b> </b></p><p><i><b>Build Organization and Inspire People</b></i></p><p>-Mentors junior team members</p><p>-Provides training and support on areas of subject matter expertise</p><p>-Proactively strengthens own leadership skills and actively uses these skills in day to day work</p><p> </p><p><i><b>Drive Results</b></i></p><p>-Encourages others to complete goals</p><p> </p><p><i><b>Make Difficult Decisions</b></i></p><p>-Interacts with cross-functional and department colleagues to help drive efficient decision-making</p><p> </p><p><i><b>Encourage an Open Environment and Knowledge Sharing</b></i></p><p>-Provides honest, accurate feedback to managers, whether positive or negative</p><p>-Not afraid to challenge peers and managers and be challenged</p><p>-Openly shares information with peers</p><br /><p><b>Minimum Education:</b></p><p> </p><p>Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, or related subject</p><br /><p><b>Minimum Experience/Training Required:</b></p><p> </p><p>A minimum of 10 years of experience in Regulatory Affairs, R&D, Manufacturing or related areas</p>