Beatrice Curran

With over 20 years experience in the pharmaceutical industry Beatrice applies her skills to a broad range of therapeutic areas and has successfully helped several large pharmaceutical clients interact with regulatory agencies. She has led cross-functional teams and a CMC small molecules team to manage various post approval challenges for medically necessary drugs.

Key areas of expertise

Therapeutic area experience including anti-infectives, anti-virals, immunosuppressants, psychiatry, ophthalmology, neurology and metabolic disorders

• Regulatory Strategy Development for marketed small molecules
• Regulatory Affairs Agency Liaison (i.e., U.S. Agent Representative)
• Regulatory Filing & Submission Requirements: Supplements to NDAs, Amendments to INDs
• Briefing Books in support of FDA Meetings, Response Documents to FDA Information Requests and FDA Complete Response Letters
• Regulatory Compliance & Reporting: NDA Annual Reports, Post-Marketing Requirement (PMR) and Post-Marketing Commitment (PMC) Interim Reports, Pediatric Research Equity (PREA), Pediatric Deferral Extension Requests, Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), Drug Safety Updated Reports (DSURs)
• Negotiated labeling with the FDA for PLLR conversion
• Authorized Generics –Regulatory Lead for all labeling and artwork for the drugs within a portfolio
• Conversion of US Package Inserts to the PLLR format

Before NDA

Beatrice has over 20 years experience in the pharmaceutical industry serving as a Global Regulatory Lead primarily in marketed small molecules supporting several therapeutic areas including infectious diseases, metabolic disorders, psychiatry, neurology and ophthalmology. Beatrice has led the submission of multiple labeling and CMC supplements to NDAs and amendments to INDs.

She has authored briefing documents and led the rehearsals for cross-functional teams prior to FDA Type A, B and C meetings. Beatrice has worked as a Global Regulatory Lead to support approved drugs and has managed a Regulatory CMC small molecules team.

Her previous work included developing global regulatory strategy documents and providing post-marketing product support to numerous drugs. In addition, she has successfully managed technical projects for several Active Pharmaceutical Ingredient’s (APIs) as part of a global support team.