Manager, Regulatory Affairs, CMC (Small Molecule or Biologics)- Remote

Regulatory Professionals United States


Position at Regulatory Professionals

Regulatory Professionals, a division of Premier Research, is a consultancy firm specializing in drug, biologics and device regulatory affairs. Our purpose as a company is to support our clients by furthering the development of human therapeutics that will benefit the health and well-being of patients around the world. With a presence in the US, EU, Canada and Japan we are growing and looking for talented people to grow our business, advance the goals of our clients and contribute to our unique culture. Our focus is to provide strategic and tactical support in all aspects of regulatory affairs, including preclinical, CMC and clinical development for drugs, biologics, devices, and combination products.

We are seeking a talented Manager, Regulatory Affairs Chemistry, Manufacturing, and Controls  to join our growing team at RPI! This position is available as a fully remote role.

The Manager, Regulatory Affairs Chemistry Manufacturing, and Controls (RACMC) provides support for CMC regulatory submissions and contributes to CMC regulatory strategies. This position is responsible for working with cross functional teams to manage the preparation, review and assembly of CMC regulatory submissions and related CMC documents. This Manager, RACMC may supervise or manage others within the RACMC skill group.

This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities.  Accommodations for new hires who have qualifying medical conditions or sincerely held religious beliefs that conflict with this requirement will be considered on an individual basis.

What you’ll be doing:
  • With some supervision, provide strategic RACMC interpretation and guidance to project teams from early development through post-approval
  • Determine from a strategic and scientific perspective the content of relevant CMC sections (technical and/or procedural) of project/product specific documents submitted to regulatory agencies (e.g. NDA, MAA, INDs, IMPDs, etc.) and ensure that these documents meet high scientific standards and regulatory requirements
  • Participate in project/product-related discussions and provide strategic, scientific and regulatory input, for CMC regulatory and/or procedural aspects
  • Support the creation of and update to quality sections of regulatory filings
  • Assist in the preparation of high quality project/product specific CMC regulatory documents to be submitted to regulatory agencies for CMC and ensure that those documents meet regulatory requirements
  • Review CMC protocols/test methods; review and approve clinical manufacturing plans and labeling, and authorize drug shipment to clinical sites
  • Support RACMC activities associated with regulatory agency meetings pertaining to a project/product
  • Provide support to other regulatory team members/leadership for key regulatory activities pertaining to a project/product
  • Review quality submission documents to ensure consistency with related filings, industry standards and regulatory requirements
  • Interact with manufacturing and quality groups, regulatory agencies, contract and partner organizations, as necessary, regarding RACMC issues
  • Assess impact of manufacturing changes pertaining to approved commercial products
  • Ensure planning, proper organization, and execution of RACMC activities in line with the overall project plan and regulatory affairs milestones
  • Be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset(s)
  • Provide coaching, mentoring and knowledge sharing within the RACMC skill group
  • Review and approve timesheets and expense reports and guide the performance of assigned staff
You'll need this to be considered:
  • Bachelor’s degree, or international equivalent from an accredited institution, in a scientific discipline; PhD preferred   
  • 8+ years of experience in the pharmaceutical, biotechnology or device/diagnostics industry, an advanced degree will be considered in lieu of a portion of industry experience   
  • 5-6 years of RACMC experience in a CRO, pharmaceutical, device/diagnostics or biotechnology company  
  • 2-3 years supervisory/management experience preferred   
  • Knowledge of regulatory requirements, including ICH and FDA  
  • Diverse experience including drugs, biologics, devices and international filings preferred•    
  • Excellent organizational, writing, communications and time management skills needed to manage multiple ongoing projects simultaneously 
  • Results driven and team orientated with the ability to influence outcomes as necessary  
  • Able to innovate, analyze, and solve problems with minimal supervision 
  • Exceptionally keen attention to detail
  • Experience in Small Molecule or Biologics