Denise Fairman, M.S., Rac Email & Phone Number

Shanghai, Cn

Work closely with functional areas and project teams to support product development and approval of novel drugs within the CNS and Oncology therapeutic areas. Participate in the development of regulatory strategies and provide strategic input and regulatory advice to the project teams. Interface with functional areas to identify and obtain information required for regulatory submissions. Provide CMC regulatory strategy for small molecule and biological drugs, provide regulatory support for new and on-going clinical trials, prepare the CMC part of the IND/NDA filings and responses to Health Authority questions related to quality. Lead the preparation and filing of the regulatory applications (IND/CTA, NDA/NLA/MAA). Develop and/or review regulatory documents to ensure all submissions are of high quality. Create and maintain regulatory timelines and track deliverables to timelines to ensure regulatory submission timelines are met.

Warrington, Pa, Us

Provided regulatory input on novel drug delivery technologies for respiratory diseases. Worked on an annual report, Investigational Brochure, PSUR, responses to Scientific Advise questions from EMEA and publishing support for an active IND that has been granted Orphan Drug Status in both US and EU for 26-28 week Gestational Age (GA) infants.

Manage the development and publication of regulatory submissions for a diverse range of products spanning creams, ointments, lotions, gels, nasal sprays, oral solutions, suppositories and OTC drug products at two locations. Align all submissions with corporate strategy and deadlines. Oversee and mentor a seven-person team of Regulatory Affairs Associates, Regulatory Specialists, a Senior Regulatory Affairs, and a contractor.Champion the department’s perspective during cross-functional projects, relaying strategy and regulatory requirements based on the dosage form. Examined projects at individual “stage-gates” as a member of the core Team Leadership and Scientific Review Board. Discussed scientific concerns and outlined strategies as necessary for moving forward.Due diligence on prospective alliances with external companies for drugs completing Phase 1 or 2 clinical trials.Submitted Controlled Correspondence (CC) and General Correspondence (GC).

Standardized submissions to FDA by introducing and transmitting eCTD templates through ESG, including original applications, amendments, supplements, annual reports, and responses to deficiencies.Supervise and mentor two Regulatory Affairs Associates.Crafted and reviewed IND amendments, original ANDA submissions, amendments, responses to deficiencies, supplements, annual reports, and periodic adverse drug experience reports (PADERs).Spearheaded the post-acquisition integration of two sites and 43 applications.Published all submissions in eCTD format and submit through ESG prior to establishment of Regulatory Operations group.Transferred sequence publication and maintenance in house after helping to identify and procure new publishing software. Annual cost savings: $125K.Evaluated regulatory impact and crafted strategies for changes in TrackWise® proposed by AR&D, Manufacturing, Packaging, Quality and Technical Services based on the CFR, FDA Guidance, and ICH Guidelines.Reviewed and authored documentation in the EDMS using Qumas.

Submitted the company’s first 505 (b)(2) and Paragraph IV applications as well as ANDAs.Submissions include oral solid dosages, nasal spray, and oral solutions.Helped write and transmit Drug Master Files (DMFs) for Active Pharmaceutical Ingredient (API) produced at Cody Laboratories, Inc., a wholly owned subsidiary. Due diligence on purchase of applications.Crafted and submitted suitability and citizen petitions about drug products to the FDA. Supervised and mentored a three-person team, including Senior Regulatory Associates.Interface with FDA project managers within OGD and OND on drug product applications.Attend pre-IND meeting with FDA.Represent RA on cross-functional project teams, working effectively with multiple disciplines and personalities

Supervise staff consisting of Senior Regulatory Associates and Regulatory Associates.Responsible for submission of supplements to ANDAs, periodic adverse experience reports (PADERs), annual reports and assess all change controls providing regulatory assessment.Assess the regulatory impact of changes proposed by R&D, Manufacturing and Technical Services based on the CFR, FDA Guidance documents and telephone contacts with FDA.

Authored 19 ANDAs and a 505(b)(2) application. Train new associates to compile and submit to FDA, original ANDAs, amendments, supplements, annual reports, labeling (package inserts, container labels, cartons and SPL) and PADERs. Review batch records, protocols, validation documents for regulatory complianceReviewed all documents prior to submission to FDAEvaluated software and helped bring in-house in order to improve the efficiency of reviewing labeling. Spearheaded submission of original ANDA applications, amendments, supplements, periodic adverse experience reports, and annual reports.Interface with FDA project managers within OGD.

Responsible for submission of original ANDA applications, amendments, supplements, periodic adverse experience reports and annual reports.Interface with FDA project managers within OGD.

New York, New York, Us

Discovery Research, NeuroscienceWorked in CNS Therapeutic Area on several project teams.Instrumental in screening compounds for Alzheimer’s Disease (Beta-Amyloid) and Neurodegenerative Diseases

Ms, Regulatory Affairs/Quality Assurance

Bachelor Of Arts - Ba, Biology