Sr Director Regulatory Affairs ROW Apply to This Job

Company: ExecuNet
Location: Durham
Posted on: February 23, 2021

Job Description:

Your role:

Reporting to the VP Regulatory Affairs, this leadership role will manage and develop regulatory staff. The incumbent will support s the drug development and registration efforts for Company's plant-based biologic products including vaccines, antibodies and monoclonals across different infectious diseases and therapeutic areas. The incumbent manages and supports the regulatory activities necessary to develop and up-date Marketing Applications for product registration in all relevant regulatory jurisdictions including ROW. This RA leadership role will be responsible for negotiating with ROW regulatory authorities, as well as interfacing and managing internal subject matter experts/CMO's involved in dossier preparation. This role is also responsible for all labelling and promotional compliance activities.

Your responsibilities:--

• Lead/plan/execute global regulatory post-approval and ROW strategy and submissions for all assigned R&D and marketed products, collaborating with various subteams to deliver against corporate timelines and broader corporate objectives in accordance with regulations and guidance;
• Serve as liaison to regulatory authorities;
• Manage, hire and mentor regulatory staff
• Ensure regulatory senior management is aligned with strategy, timelines, risks, and mitigations with the goal of presenting a unified regulatory position;
• Identify, review and establish Regulatory Affairs SOPs and RA processes for Post Approval and ROW activities;
• Review and approve global technical documents for regulatory submissions, ensuring compliance and alignment with regulatory requirements and strategy;
• Lead special projects in coordination with internal and external stakeholders;--
• Coordinate the timelines and work with both internal and external stakeholders and/or staff to meet departmental and corporate goals;
• Act as a point of contact for all specific Regulatory Post-approval and ROW subject matters or topics;
• Represent the department internally on committees and intra-functional projects;
• Responsible for identifying and implementing innovative initiatives in support of corporate objectives;
• Responsible for setting short-term goals and negotiating with necessary points of contact to achieve said goals;
• Present key up-dates to regulations, guidelines and processes to senior management;
• Oversee the promotional compliance team and may negotiate with promotional compliance agencies;
• Oversee the labelling team and may negotiate labelling with regulatory agencies;
• May provide analysis, trends and impact of surveillance of key Health Authority activities, including key approvals of competitor products and to the promotional compliance and labelling landscape;
• May lead the publishing operations team The profile we are looking for :
  • Master's degree in a biological science related field (an advanced degree is highly desirable) is required with proven leadership and program management experience.
  • A minimum of 15 years of experience or equivalent of regulatory drug development of biologic products , expert knowledge of regulatory affairs for biologics within one or more therapeutic areas, preferably infectious diseases, including 5 years in Vaccines is required.
  • Expert knowledge of global regulatory agencies and regulatory submission processes and ability to find material and information
  • Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority is required
  • A scientific understanding of the regulatory data requirements including experience with multiple regulatory disciplines (i.e., CMC, regulatory intelligence, clinical development, etc.) is preferred.
  • Regulatory experience with approved products, labelling and promotional compliance is required.
  • Demonstrated experience in leading teams to prepare for Major Health Authority interactions (e.g. FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, etc.) and attending Health Authority meetings is preferred.
  • Excellent knowledge of regulatory information system (RIM)/electronic document management system (EDMS)--
  • Demonstrated successful publishing experience of complex eCTD submissions--
  • Demonstrated understanding of global promotional compliance agencies and submission processes, ability in negotiating and find regulatory material and information--
  • Expert understanding of GLP / GMP / GCP
  • Must have a proven track record of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities and demonstrate a proven track record of excellent influencing and negotiating skills.
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