DIRECTOR OF REGULATORY AFFAIRS SKILLS, EXPERIENCE, AND JOB REQUIREMENTS

Published: Feb 17, 2025 – The Director of Regulatory Affairs has experience in regulatory affairs within biopharmaceutical organizations, with a strong focus on developing and executing global regulatory strategies that drive successful submissions and product launches. This role requires a deep understanding of the drug development process, particularly in orphan drugs, along with expertise in FDA, EMA, and PMDA regulations and direct interactions with regulatory authorities. Strong communication and leadership skills enable effective stakeholder influence, collaboration with scientists and clinicians, and navigation of complex regulatory landscapes in fast-paced, high-growth environments.

Essential Hard and Soft Skills for a Standout Director of Regulatory Affairs Resume
  • Regulation Management
  • Compliance Assurance
  • Data Preparation
  • Trial Oversight
  • Regulatory Strategy
  • Global Compliance
  • Product Registration
  • Safety Monitoring
  • Budget Management
  • Submission Oversight
  • Agency Interaction
  • Team Leadership
  • Training Delivery
  • Change Management
  • Cross-Functional Collaboration
  • Agency Communication
  • Clinical Strategy Alignment
  • Process Improvement
  • Staff Mentoring
  • Problem Solving

Summary of Director of Regulatory Affairs Knowledge and Qualifications on Resume

1. BS in Public Health with 8 years of Experience

  • Expertise in Pharmaceutical Regulatory and FDA process and interface
  • Knowledge of FD and C Acts, other current related regulations, and FDA guidelines
  • Experience with submissions, BLAs, and INDs.
  • Working experience in clinical/bioequivalence studies and devices
  • Strong management skills, effective problem-solving skills
  • Clear communication skills, highly proactive, strategic thinking, and commitment to timelines
  • Excellent influencing and interpersonal skills
  • Fluency in English and German, other languages
  • Proactive, business acumen, client focus, setting priorities, well organized, getting things done mentality
  • Has an external focus and understands international market dynamics
  • Understanding the graphical or packaging market is an advantage
  • Be a team player with a results-driven mindset, whilst remaining accurate and standing firm when needed

2. BS in Biomedical Engineering with 10 years of Experience

  • Experience in a significant corporate regulatory within an FDA-regulated drugs and devices industry
  • Comprehensive knowledge of FDA, and cGMP (mandatory).
  • Well-versed with 21 CFR 803 (Medical Device Regulations)
  • Experience with international GMP/RA compliance requirements, especially EMEA, Latin America and Canada.
  • Proven record for exceeding quality and business goals
  • Thorough understanding and working knowledge of 510(k) and PMA submissions, and ANDAs
  • Expertise to command regulatory compliance activity in alignment with corporate policies and industry regulations
  • Strong organizational and time management skills - high attention to detail
  • Self-starter with strong interpersonal skills
  • Strong Communication skills - Written, Oral, and Presentation
  • Relevant management experience in a comparable role in the food contact materials sector like ink, packaging, chemicals or related industries
  • Up-to-date chemical knowledge and familiarity with relevant international legislation and requirements
  • Comfortable working in an international organization with various stakeholders

3. BS in Biomedical Engineering with 11 years of Experience

  • Regulatory affairs experience within biopharmaceutical organizations
  • Have been in a global capacity with a focus on driving and implementing sound regulatory strategies leading to successful submissions and launches
  • Prior experience working in rapidly growing pharmaceutical organizations
  • A thorough understanding of the drug development process with expertise in orphan drugs, along with knowledge of the developing landscape of regulations and guidelines
  • Demonstrated ability to coordinate the development of critical regulatory documents involved in the approval of medicines with a focus on FDA, EMA, and PMDA
  • Affinity with science and ability to interact with scientists and clinicians
  • Experience interacting with regulatory authorities, especially the FDA
  • Ability to speak and interact with a diverse group of individuals on technical and business topics
  • Familiarity with current and emerging regulatory legislation, industry trends, and healthcare business practices
  • A clear communicator who can influence stakeholders effectively, both internally and externally
  • Outstanding presentation, written and verbal communication skills
  • Excel in a fast-paced, results-driven, highly accountable environment
  • Be pragmatic, yet creative and innovative, and lead while "rolling up your sleeves" to get it done

4. BS in Health Sciences with 12 years of Experience

  • Previous experience that provides the knowledge, skills, and abilities to perform the job 
  • Decisive and strong leadership as well as interpersonal skills
  • Superior English language communication and negotiation skills, as well as local language where applicable, both oral and written
  • Excellent understanding of global/regional/national country requirements and regulatory affairs procedures for clinical trial authorization, licensing and lifecycle management
  • Superior understanding of ICH and other global regulatory guidelines
  • Advanced knowledge of at least one of the regulatory specialty areas: preclinical, clinical, CMC, publishing, etc.
  • Advanced understanding of budgeting and forecasting with the ability to interpret data with attention to detail and analytical and investigative skills
  • Capable of supervising, evaluating, and mentoring departmental personnel, as well as delegating tasks and facilitating the completion of assignments
  • Capable of driving innovation in developing new ideas related to process improvements
  • Excellent organizational, judgment, analytical, decision-making, and interpersonal skills to manage complex projects in parallel and manage rapidly changing priorities
  • Effective computer skills, including the use of Microsoft (MS) Word, MS Excel, Adobe Acrobat, etc.
  • Capable of independently assessing sponsor needs and working with project team members in producing compliant deliverables
  • Capable of independently learning new technologies
  • Capable of effectively acting as a liaison with other departments
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