Majella Dooley

About Majella Dooley

Over 25 years of experience in pharmaceutical drug development including 20 years experience in Regulatory AffairsExtensive knowledge of the drug development process for pharmaceutical productsStrategic and hands on roles in the preparation of significant US and ex-US (EU and Canada) regulatory submissions, including INDs, CTAs, NDAs, sNDAs, Scientific Advice Briefing Packages and SupplementsKey communicator with FDA and ex-US regulatory authorities. Regulatory Affairs representative to project teams with direct communication to corporate management and colleagues within the companyExperience with the following therapeutic areas: acute pain, neuropathic pain, procedural sedation, antibiotics, diabetes, oncology and women’s healthKnowledge of US and EU regulations and ICH guidelines

Experience

1. Executive Director, Regulatory Affairs

   An2 Therapeutics

   Jan 2024 — Present · Menlo Park, CA, US

   Develop and implement global regulatory strategies for product development, registration, and lifecycle managementEnsure compliance with all relevant regulations and guidelines, including those related to clinical trials and marketing applications.Oversee the preparation, review, and submission of regulatory documents to health authorities, including CTAs and INDs, Builds and maintains strong relationships with regulatory agencies, internal stakeholders, and external partners.Works closely with other departments, such as clinical and research to ensure alignment on regulatory strategies and objectives.Develop and implement regulatory policies, processes, and standard operating procedures.

Education

• Dublin City University

  BSc(hons), Analytical Sciences

  1985 — 1989

Skills

• Cmc
• Clinical Trials
• Technology Transfer
• Regulatory Submissions
• Clinical Development
• Clinical Research
• Drug Development
• Oncology
• Ind
• Validation
• Commercialization
• Regulatory Affairs
• Fda