Associate Director of Regulatory Affairs

Resolvit.com - Remote

RESOLVIT

Bringing Solutions That Make Business Better

Join Resolvit as an Associate 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 Associate Director of Regulatory Affairs, you will ensure the coordination and management of post approval, ROW, labeling, and promotional compliance regulatory documents related to activities in all regulatory jurisdictions. You will manage and develop regulatory staff and will support development and registration efforts for plant-based biologic products including vaccines, antibodies, and monoclonals across different infectious diseases and therapeutic areas. You will also coordinate, prepare, and maintain registration and post-approval dossiers, including labeling and promotional compliance activities. Additionally, you will:

  • Interface and manage internal subject matter experts and CMOs involved in these activities
  • Lead, plan, and execute post approval and global regulatory submissions, including timelines, for all assigned products, collaborating with both internal and external stakeholders and/or staff to deliver against corporate timelines and broader corporate objectives in accordance with regulations and guidance
  • Write and/or review technical documents for global regulatory submissions to ensure compliance and alignment with global regulatory requirements and strategy
  • Lead special projects in coordination with internal and external stakeholders
  • Train and mentor regulatory staff and support other SMEs in regulatory requirements within designated functional areas
  • Identify, review, and implement regulatory affairs SOPs and RA processes
  • Act as a point of contact for delegated regulatory post approval, ROW, labelling, and promotional compliance subject matters or topics
  • Represent the department internally on committees and intra-functional projects
  • Implement innovative initiatives in support of corporate objectives
  • Lead the labelling team for label development and maintenance of designated products
  • 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

What You’ll Need to be Successful:

  • At least 7 years or relevant experience, including experience as a supervisor
  • Post graduate degree in a relevant field (biological or chemical sciences)
  • Comprehensive knowledge of global regulatory agencies and regulatory submission processes and ability to find material and information
  • Demonstrated ability to complete larger regulatory dossiers and ensure consistency between individual document content of a large submission
  • Regulatory experience with approved products, labelling, and promotional compliance
  • Comprehensive understanding of global promotional compliance agencies and submission processes
  • Demonstrated experience in labelling submission processes
  • Demonstrated successful experience in ROW regulatory agency interactions and major submissions and approvals
  • Comprehensive understanding of GLP/GMP/GCP
  • Excellent verbal and written communication skills
  • Excellent attention to detail
  • Demonstrated ability to defend difficult positions and sway opinion
  • Demonstrated ability to align teams, including regular cross-functional interactions with external vendors and other departments
  • Comprehensive knowledge of Office Suite

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: Tuesday, July 20, 2021



Apply to this job
  • 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.