Tanzir Mortuza
Hopkinton
Summary
Strategic regulatory CMC leader with expertise in planning, team leadership, and performance optimization. Drives organizational growth through efficient regulatory strategies and strong stakeholder relationships. Delivers innovative solutions that align with organizational goals, leveraging problem-solving and decision-making skills to influence key stakeholders.
Overview
9
9
years of professional experience
Work History
Associate Director, Regulatory Affairs CMC, Biologics
BeOne Medicines
Cambridge
04.2024 - Current
- Acted as the regulatory CMC representative on project teams for a marketed mAb oncology product.
- Provided CMC regulatory support and guidance for projects and interfaces with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues.
- Managed interactions with EMA, Health Canada, Swissmedic, MHRA, and other global regulatory authorities for assigned projects, facilitating acceptance and rapid approval of marketing applications, supplements, clinical trial applications, and other CMC submissions.
- Represented regulatory CMC function during EMA inspection at a new biologics manufacturing site located in China.
- Managed and authored 20+ global MAA and other CMC variations to EMA, Health Canada, Swissmedic, MHRA and other global regulatory authorities.
- Developed and implemented regulatory CMC strategies for global submissions, aligning with drug product life cycle during commercialization and interpreting local regulations and guidance for effective application.
- Managed CMC document packages for regulatory submissions in support of commercial programs. This included lifecycle management submissions to Health Authorities (HAs), and preparation of responses to questions from HAs balancing HA requirements and corporate objectives.
- Reviewed technical reports and CMC sections of BLA, MAA, and other global submissions to support and marketing applications, and their amendments in conformance with regulatory requirements, strategies, and commitments.
- Worked with regulatory CROs to identify regional/country-specific CMC requirements to support global applications.
- Evaluated proposed manufacturing changes for global impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes.
- Maintained knowledge of global competitive landscape and regulatory environment, interpreting CMC guidance for internal stakeholders and initiating process improvements to enhance compliance and efficiency.
Senior Manager Regulatory Affairs
Gilead Sciences
Foster City
05.2022 - 03.2024
- Led a team of regulatory experts (1 FTE + 2 contractors) in developing global regulatory CMC strategy and submissions for mAb and analytical modality of marketed ADC (Trodelvy) oncology product.
- Served as the CMC point of contact to FDA.
- Led complicated and timeline critical CMC post-approval life-cycle management submissions and information requests in US (10+ PAS/CBE30 submissions).
- Executed staggered and bundled submission strategy for multiple variations across regions, ensuring timely regulatory submissions.
- Managed global clinical submissions for multiple studies.
- Facilitated multi-day submission workshop with technical, quality, and supply chain teams to coordinate large bundled analytical submission (40+ change controls).
- Collaborated with regional leads and technical teams to ensure timely submissions and approval of all critical CMC related changes.
Manager Regulatory Affairs
Takeda Pharmaceutical Company Limited
Lexington
02.2021 - 05.2022
- Led global regulatory CMC strategy for a PRIME designated Phase III rare disease clinical program with external organization (Japanese).
- Led CMC post-approval life-cycle management submissions in Tier 1 (US-PAS, CBE-30, Annual Report; EU-Type II, Type IA/IB; Canada- Level 1, 2 and 3, YBPR) and global markets (Switzerland, Serbia, Israel, Australia, New Zealand) for Takhzyro.
- Led RTQ/IR submissions for Takhzyro in Tier 1 and global markets, ensuring timely and accurate responses to health authority inquiries.
- Executed high-priority CMC submissions including new manufacturing site approval and complex change variations for combination product, facilitating regulatory compliance and market access.
- Provided regulatory feedback on critical CMC milestones, influencing Brazil approval, commercial material launch, and drug substance manufacturing site selection.
- Evaluated CMC change controls of clinical and marketed products for major markets.
- Reviewed and provided feedback on CMC related health authority interactions (e.g.- EMA PRIME meeting briefing book and presentation).
- Supported regulatory activities (e.g. – submission, review of documents) for complete response letter (CRL).
- Shared regulatory intelligence experience with the team to initiate CMC regulatory benchmarking tool.
Regulatory Specialist
Merck & Co., Inc.
Kenilworth
09.2018 - 02.2021
- Led and implemented global CMC submission activities (planning, authoring, reviewing, coordination, submission) of an oncology umbrella project consisting of six products that included two combination therapy and two marketed products.
- Reviewed and submitted CMC dossier for investigational new drug (IND), investigational medicinal product dossier (IMPD), clinical trial application (CTA) applications, major CMC amendments, and annual reports for biologics to regulatory agencies (e.g. FDA, EMA) applying CMC global regulatory strategies, current regulatory trends and guidelines.
- Authored quality overall summary in INDs/IMPDs and summary of changes in annual reports and amendments.
- Prepared and communicated CMC risk management assessments and lessons learned from major submissions to stakeholders, enhancing decision-making and project alignment.
- Ensured technical congruency and regulatory compliance upon technical and regulatory team alignment on timelines and e-publishing requirements.
- Communicated CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and major stakeholders.
- Formulated global CMC regulatory strategy through development of regulatory strategy documents, ensuring innovation and compliance for biologics products.
- Identified documentation and content for global submissions and negotiated delivery of approved technical source documents with technical team.
- Managed submission time-lines of IND, pre-IND meeting package, and investigator’s brochure (IB).
- Led CMC related health authority interactions (e.g.- RTQs, FDA/EMA meeting package submission).
- Negotiated internal and external submission timelines with health authorities and internal stakeholders (e.g.: extension on RTQs, CMC deliverable timeline with clinical team).
- Evaluated regulatory impact of Brexit on quality person declaration (QPD) process and regulatory submissions.
- Provided regulatory expertise to the multifunctional teams to initiate timeline, finalize documents, and clinical bridging.
- Negotiated with country representatives to modify requirements indicated in the CRDb to avoid confusion in regulatory filings.
- Formulated change control overdue items tracker and communicated with the project CMC managers to timely close out of the open items to mitigate regulatory non-compliance.
- Assessed regulatory impact of manufacturing changes on investigational and approved biologics.
- Provided industry feedback to the US and China regulatory agencies on draft guidance.
- Participated in partnership road map initiative to foster collaborative relationships across organizational platforms with internal and external stakeholders, including industry organizations and government agencies.
- Acted as on-boarding buddy to newly hired employees to facilitate on boarding to achieve better business goals.
Career Development Scientific Rotation
Merck & Co., Inc.
Kenilworth
04.2019 - 12.2019
- Performed scientific rotations in upstream, downstream and analytical process development areas for three months each.
- Conducted cell culture laboratory work (shake flasks and bioreactors), cell culture media and feed optimization, process development and optimization.
- Collaborated with technical operations and biologics production teams to ensure successful execution of pilot scale and clinical manufacturing upstream operations.
- Contributed to large scale (50 L) continuous biologics manufacturing process within emerging technology team, optimizing end-to-end biologics manufacturing.
- Implemented product-development strategies through design of experiments (DoE) to enhance product yield and process efficiency.
- Purified proteins using chromatography systems (ProA, AEX, CEX).
- Analyzed data to interpret and integrate experimental results with project objectives.
- Performed binding ELISA potency assay to evaluate potency of a biologics product on its target.
Intern
Merck & Co., Inc.
West Point
05.2017 - 08.2017
- Enhanced regulatory intelligence database for responses to questions (RTQs) for non-Merck products by analyzing FDA and EMA documents to improve access to regulatory information.
- Investigated trends in regulatory questions from FDA and EMA for biologics to identify key areas of focus for compliance and strategic planning.
- Reviewed International Conference of Harmonization (ICH) common technical document (CTD) for Module 3 (CMC) requirements.
- Reviewed International Conference of Harmonization (ICH) common technical document (CTD) for Module 3 (CMC) requirements to ensure alignment with global regulatory standards.
Education
Doctor of Philosophy - Pharmacy
University of Georgia
Athens, GA08-2018
Clinical Trials Design and Management Certificate -
University of Georgia
Athens, GA05-2016
Pharmaceutical and Biomedical Regulatory Affairs Certificate -
University of Georgia
Athens, GA05-2016
Bachelor of Science - Biochemistry and Molecular Biology
University of Georgia
Athens, GA12-2009
Skills
- CMC regulatory strategy
- Global submission management
- Health authority interactions
- Regulatory submissions
- CMC documentation authoring
- Regulatory change control
- Project management
Honors And Awards
- UGA College of Pharmacy 60 at 60 (2021)
- John Doull Risk Assessment Endowment Award, SOT (2017)
- 2nd prize in Platform Presentation – South-east Society of Toxicology Meeting Fort Valley, Georgia (2017)
- Outstanding Teaching Assistant, UGA Graduate School (2017)
- 1st prize in Poster Presentation – South-east Society of Toxicology Meeting Tampa, Florida (2015)
Scientific Publications
9, 8, 7, 15, https://scholar.google.com/citations?user=j7MwPlYAAAAJ&hl=en
Teaching And Mentoring
- Teaching Assistance, Department of Pharmaceutical and Biomedical Sciences, University of Georgia, 08/01/12-08/01/18
- Student Outreach and Development, Department of Pharmaceutical and Biomedical Sciences, University of Georgia, 08/01/12-08/01/18
Leadership Experience
- Chair, Society of Toxicology (SOT) Graduate Student Leadership Committee (GSLC), 2017-2018
- Chair, American Association of Pharmaceutical Scientists (AAPS) UGA Chapter, 2015-2016
- Chair, AAPS Biotechnology Section Student Committee (BSSC), 2014-2016
Timeline
Associate Director, Regulatory Affairs CMC, Biologics
BeOne Medicines
04.2024 - Current
Senior Manager Regulatory Affairs
Gilead Sciences
05.2022 - 03.2024
Manager Regulatory Affairs
Takeda Pharmaceutical Company Limited
02.2021 - 05.2022
Career Development Scientific Rotation
Merck & Co., Inc.
04.2019 - 12.2019
Regulatory Specialist
Merck & Co., Inc.
09.2018 - 02.2021
Intern
Merck & Co., Inc.
05.2017 - 08.2017
Doctor of Philosophy - Pharmacy
University of Georgia
Clinical Trials Design and Management Certificate -
University of Georgia
Pharmaceutical and Biomedical Regulatory Affairs Certificate -
University of Georgia
Bachelor of Science - Biochemistry and Molecular Biology
University of Georgia