Global Regulatory Affairs CMC (Consultant) - Takeda Pharmaceuticals
(2025-05 - 2026-04)
Supporting Neurology and Oncology programs- Small Molecule
- NDA activities-Providing support for M3 review in Mediva, change controls, risk assessments, briefing book authoring strategy (Type C), leading PACMP for site changes post NDA submission
- IMPD activities-Providing support for activities like EU CTR RTQ
- Interim lead for Oncology program in Marketed Products
- Created Protocol for Dossier gap analysis, led India MAA and Marketed Product Playbook, Change Controls support
Lead Candidate for Director Reg CMC Role - Moderna - Norwood, MA
(2025-03 - 2025-04)
Rare disease - Waited for the offer and position was eliminated June 2025
Director Regulatory CMC Strategy - PepGen - Boston, MA
(2024-04 - 2025-02)
Antisense Oligonucleotide Platform, Rare Neuromuscular disorder Phase 1/2. Position impacted by agency feedback on the lead drug Dec. 2024
- Set up a new Regulatory CMC function
- Developed regulatory processes and procedures to support CMC components of Regulatory Submissions and performing gap analysis
- Led preparation of high-quality license applications IND/IMPD specific to CMC content and support with templates
- Supported HA responses UK, Canada, EU-BfArM
- Provided guidance on Regulatory CMC aspects of product development phase including planning HA meetings
- Developed/implemented effective CMC regulatory strategies for Submission e.g IND/CTA/NDA/MAA) and identify regulatory risks
- Provided strategy for EOP 2 meeting, Phase III and NDA, while planning CDMO and technology change
- Provided CMC regulatory guidance to Manufacturing and quality teams, evaluate CMC change controls
- Performed assessments of manufacturing change controls and provide guidance on process improvement
Associate Director Regulatory CMC GRA - Vertex Pharmaceuticals - Boston, MA
(2022-04 - 2024-03)
Regulatory CMC/Lead Strategist for Cell and Gene therapy programs in CGT
- Led the IND authoring for the Gene Therapy program for FIH study, storyboarding within templates, performing regulatory risk assessment, technical reports planning -plasmid design, upstream and downstream from contract manufacturers
- Managed HA meeting-KOM and storyboarding for PEI Germany, FDA Type C
- Supported the Heme program during BLA filing to review gaps
- Supported diabetes program with regulatory strategy for both cells and device and improving CC process
- Supported COE for technology transfer initiatives
- Process improvement in management of Change Controls
- Collaborated with QA, functional team, Clinical RA, project Management
Senior Manager Regulatory CMC GRA - Takeda Pharmaceutical - Cambridge, MA
(2020-06 - 2022-04)
Regulatory CMC strategist/lead for EDG Programs– nanoparticle, enzyme base orals, microbiome, mAb and small molecule
- Led/managed writing, preparation review and approval of regulatory CMC dossier for submission: IND, IND amendments, Annual Reports, FDA meeting requirements Type D (BB/MR), IB, PIP, FDA information request
- Provided interpretation of Regulatory guidance, regulations and directives to product /analytical development group regarding their applicability
- Worked with Regulatory ops, submission management to support development of internal process
- Collaborated with GRA to develop Global CMC Regulatory strategy and risk mitigation
- Identified CMC risks with the technical team, support regulatory compliance with change controls, quality activities audit findings, review RFP, SOW and participate in CDMO selection process
- Participated in HA meeting Type C written response, followed by teleconference on Microbiome project
Manager Regulatory CMC GRA - Takeda Pharmaceutical - Cambridge, MA
(2018-03 - 2020-06)
Reg. CMC Lead for Early development projects / New Modalities
- Led programs in various therapeutic areas GI, Neurology, Oncology
- Member of COE cell banking, bioinformatics
- Worked with the Submission managers on kick off meetings, please review and key project timelines
- Tracked and supporting with annual report, IND Amendments, FDA IR, IND, IMPD, filing the Canada DMF
- Initiated collaboration with VBU for microbiome project on animal derived media and initiating risk assessment
Manager Regulatory Affairs CMC, Medical Development - AMAG - Waltham, MA
(2017-05 - 2018-03)
US based Maternal Health products, DS/DP Small molecule/device Combination products
- Managed Drug Substance and Drug Product CMC submissions updates e.g, Annual reports, CBE-0, CBE-30 and PAS
- Participated in meetings to respond to agency questions for submissions, understand agency responses to Type B meeting Pre sNDA questions
- Provided regulatory assessments of manufacturing changes for CMOs within the change control system and provide filing strategy guidance to Technical Operations and Quality department
- Developed and implement short and long-term regulatory CMC strategies for assigned projects and programs with key partners and stake holders e.g pharmaceutical Development and Technical Operations
- Supported regulatory compliance with respect to filing requirements
Regulatory Associate II Global Regulatory Affairs, CMC Biologics - Sanofi (Genzyme) - MA
(2014-01 - 2017-05)
Global Site CMC support for Fabrazyme, Thyrogen, Cerezyme) Orphan Drug
- Managed and maintained the Quality and regulatory compliance of Fabrazyme/Cerezyme dossier by providing assessments for Deviations and GMP investigations
- Improved the Change Control Process based on Sanofi SOPS and ICH Q12 principles
- Managed the review and assessment of change controls for impact on US and EU regulatory filings and supported GRA by working along RA International colleagues
- Collaborated with cross functional teams-Manufacturing, Analytical, Facilities
- Regulatory CMC person in plant (PIP) for Global Cell banking for multiple products (commercial and development)
- Managed regulatory review and approval of technical documentation i.e. technology transfer protocols (cell banks from development to industrial operations), validation protocols, PV reports, specification development reports
- Managed Mass Biologics Site CMC regulatory tasks: Batch record review, document change review, project specific regulatory support
- Provided CMC Regulatory Strategy and CMC project support (UF/DF, Expanded Roller Bottle, Reprocessing, Harvest extension)
- Collaborated with EU colleagues to review CMC variation documentation to support Submission (EMA) for DCP gap closure
- Supported regulatory submissions (BLA supplements, Annual report, YBPR)
- Collaborated with Japan, EU and Canada on strategy and support Asia Pacific region with submissions
- Supported Dossier Compliance Program using eCTD for US, EU
- Provided support for Health Authority inspections and site related meeting
Principal Compliance Specialist - Genzyme - Allston, MA
(2012-07 - 2013-12)
Commercial DS/DP Mfg CMC Cerezyme) Orphan Drug
- Supported Regulatory Compliance for approved products Site Master File, Inspection Readiness team, audit response
- Provided Health Authority Audit support and managed site
