Senior Director of Regulatory Affairs

Resolvit.com - Remote

RESOLVIT

Bringing Solutions That Make Business Better

Join Resolvit as a Senior Director of Regulatory Affairs and be part of a creative, forward-thinking team. Our success at deploying skilled, highly knowledgeable experts has landed us on the Inc. 5000 list of America’s fastest-growing companies four times – and we’re just getting started.

As the Senior Director of Regulatory Affairs, you will manage and develop regulatory staff. You will support the drug development and registration efforts for plant-based biologic products including vaccines, antibodies, and monoclonals across different infectious diseases and therapeutic areas. You will also manage and support the regulatory activities necessary to develop marketing applications for product registration. Additionally, you will:

  • Coordinate, prepare, and maintain INDs/clinical trial applications as well as registration and post-supplement dossiers
  • Negotiate with regulatory authorities and interface with and manage internal subject matter experts and CMOs involved in dossier preparation
  • Lead, plan, and execute global regulatory CMC strategy and submissions for all assigned R&D and marketed products
  • Collaborate with various sub-teams including manufacturing (DS, DP), quality control, quality assurance and other CMC regulatory staff to deliver against corporate timelines and broader corporate objectives in accordance with regulations and guidance
  • Identify and implement innovative initiatives in support of corporate objectives
  • 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
  • Review and approve global CMC 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 CMC subject matters or topics
  • Represent the department internally on committees and intra-functional projects
  • Set short-term goals and negotiate with necessary points of contact to achieve goals
  • Present key updates to regulations, guidelines, and processes to senior management
  • Lead preparation of simple to complex e-CTD compliant documents and interact with eCTD division(s)
  • Provide analysis, trends, and impact of surveillance of key Health Authority activities, including key approvals of competitor products, to the CMC landscape
  • Lead the regulatory publishing operations

What You’ll Need to be Successful:

  • At least 15 years of relevant experience, including Director-level experience
  • PhD or MS in biological or chemical sciences
  • Expert knowledge of global regulatory agencies and regulatory submission processes and ability to find material and information
  • Demonstrated successful experience in regulatory agency interactions and major submissions (INDs/CTAs, BLA/NDS/MAA)
  • Excellent knowledge of regulatory information systems (RIM) and electronic document management system (EDMS)
  • Expert understanding of GMPs and current FDA/ICH/Health Canada/MHLW regulations and guidance
  • Excellent knowledge of MS Office Suite
  • Demonstrated ability in completing larger regulatory documents such as M2 CMC summaries and overviews, M3 DS and DP sections, and ensuring consistency between individual document content of a large submission
  • Demonstrated successful publishing experience of complex eCTD submissions
  • Expert knowledge of applicable document management and publishing tools

Benefits:

At Resolvit, you’ll be given the support you need to grow in your consulting career. In addition to opportunities for advancement, we offer:

  • Medical, dental, and vision insurance
  • Life insurance coverage
  • Long-term and short-term disability coverage
  • 401(k) retirement plan with matching
  • Professional support from our Client & Employee Optimization Specialist

We currently have more than 100 open career opportunities across the country, so be sure to mention the appropriate Job Code with any correspondence!

About Resolvit:

Resolvit is an international technology consulting firm with industry-leading customers in the financial services, high tech, manufacturing, retail, life sciences, and government sectors. Through its partnerships, Resolvit delivers highly impactful, innovative solutions across five core areas: Infrastructure Modernization, Application Development Services, Enterprise Data Management & Analytics, Knowledge & Content Management, and Strategic Staffing.



Posted On: Wednesday, March 3, 2021



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  • It is the policy of Resolvit, LLC to provide and administer employment, training, compensation, promotion, benefits and employment practices without regard to race, color, religion, national origin, ancestry, sex, sexual orientation, age, disability, medical condition, veteran status, marital status, or political affiliation.