Manager​/Sr Manager, Regulatory Affairs

Role Summary

Senior Manager / Manager, Regulatory Affairs responsible for leading CMC regulatory execution, coordinating global submissions, and providing strategic regulatory input within a fast-paced regulatory team. This onsite role is based in Germantown, Maryland.

• Lead CMC Regulatory execution for specific programs at all stages of development
• Provide strategic Regulatory input to the Manufacturing and Quality organizations pertaining to global product development requirements
• Lead the development of CMC documentation pertaining to global Regulatory filings (IND, IMPD, BLA, etc.) and responses to Health Authority requests with authoring support from Manufacturing and Quality team members, including amendments to clinical and commercial manufacturing changes
• Responsible for the coordination and management of global submissions, maintenance of product compliance, and management of change control related activities
• Leverage both technical and regulatory knowledge to proactively mitigate risks
• Serves as the Regulatory Affairs CMC representative in cross-functional and team meetings
• Execute regulatory policies and operational processes to deliver high quality regulatory submissions
• Interface with functional areas (Research (preclinical), Clinical, Manufacturing, QA, QC, and Regulatory Operations) to identify and obtain information required for regulatory submissions
• Assist with preparing/coordinating/filing/managing regulatory applications, annual reports, and information amendments for multiple products
• Maintain knowledge of current global rules, regulations, and guidance documents governing pharmaceuticals
• Collaborate in cross-functional teams
• Assume additional responsibilities as requested
• Demonstrate flexibility, i.e. willingly take on new tasks

• Required:
  
  Bachelor’s degree in Life Science or Regulatory Science or related field. RAC highly preferred.
• Required:
  
  Minimum of 7 years of experience in the biotech/pharmaceutical industry, and a minimum of 5 years in regulatory affairs in a clinical-stage and/or commercial biotechnology company
• Preferred:
  Experience in Rare Disease
• Preferred:
  Experience leading and developing CMC sections of Biologics marketing applications
• Required:
  
  Solid understanding of drug development process and the pharmaceutical industry including global regulatory CMC requirements, guidance, accelerated regulatory review paths, and policy trends
• Preferred:
  Knowledge of EU and international regulations related to clinical and nonclinical development
• Required:
  
  Ability to work independently to manage multiple projects in a fast-paced environment
• Required:
  
  Ability to effectively collaborate in a dynamic, cross-functional environment to meet each program’s critical regulatory milestones
• Required:
  
  Ability to effectively communicate the regulatory strategy, risks, mitigations, and overall plans to Project/Program Teams and senior management
• Required:
  
  Outstanding communication skills (verbal and written), regulatory writing skills and willingness to share knowledge with strong attention to detail
• Required:
  
  Excellent knowledge of Adobe and MS Office (Word, Excel, PowerPoint)
• Preferred:
  Knowledge of Veeva Vault and Regulatory Templates
• Required:
  
  Ability to learn new software quickly

• Strong organization and time management
• Excellent attention to detail
• Effective cross-functional collaboration and stakeholder coordination
• Clear regulatory strategy articulation and risk management
• Strong written and verbal communication

• Bachelor’s degree in Life Science or Regulatory Science or related field. RAC highly preferred.