Nicole Dziedzic
Middlesex,NJ
Summary
Seasoned Regulatory Professional with strong background in global and US Regulatory Affairs for several therapeutic areas, including Oncology, Hematology, and Cardiovascular & Metabolism. Demonstrated ability to work collaboratively with cross-functional teams. Working knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines, and enforcement trends. Highly organized and goal-oriented with proven success at managing multiple projects simultaneously within a fast-paced and challenging environment. Leverages strengths including strong interpersonal skills with the ability to influence others in a positive and effective manner, without authority.
Overview
10
10
years of professional experience
Work History
Regulatory Advertising and Promotion (RAP) SHADOW
Johnson & Johnson
Titusville, NJ
07.2023 - Current
- Shadowed Copy Approval Committee (CAC) meetings for SPRAVATO (esketamine) and SYMTUZA (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) and participated in discussions with cross-functional team to review promotional pieces and ensure they have fair balance and are truthful and non-misleading by appropriate representation of the Important Safety Information (ISI)
- Observed development of promotional pieces from concept to finalization and FDA sampling of the materials including the SYMTUZA booth and wall design for the United States Conference on HIV/AIDS (USCHA), SYMTUZA social media campaign, SPRAVATO booths and slide decks for Neuroscience Education Institute (NEI) Congress, and SPRAVATO treatment center toolkits
- Attended Labeling Working Group (LWG) meetings to ensure support for anticipated promotional messages and claims consistent with approved labeling
- Maintained current awareness of the regulatory landscape with regards to recent OPDP Enforcement Actions including Warning Letters and Untitled Letters and communicate to relevant stakeholders how it impacts promotions for our products.
Global Regulatory Affairs, Oncology, Cardiovascular & Metabolism (North America)
Johnson & Johnson - Janssen Inc.
Raritan, NJ
11.2019 - Current
- Manager, Regulatory Affairs Scientist
- Lead Regulatory Affairs Scientist
- Support Oncology marketed products (DARZALEX (daratumumab) and DARZALEX Faspro (daratumumab and hyaluronidase-fihj)), Oncology investigational products including CAR-T and bispecific therapies, and cardiovascular and metabolism investigational products including an oral anti-coagulant
- Significant contributions to the approval of DARZALEX Faspro as the first FDA-approved treatment for newly diagnosed adult patients with light chain (AL) amyloidosis
- Provide support for marketing applications that utilize accelerated pathways and FDA Pilot Programs including Project Orbis and the Assessment Aid
- Act as back-up contact for communications directly with the FDA
- Articulate and offers practical solutions in leading the preparation of Meeting Requests and Briefing Book documents for planned FDA meetings
- Flexible and adaptable with coordinating urgent FDA requests and ad hoc FDA meetings
- Demonstrates competence and poise in a high-pressure environment by managing FDA interactions and leading a cross-functional team to provide high-quality responses to urgent FDA requests in a timely manner
- Strong experience with prioritizing assignments for multiple projects occurring simultaneously as demonstrated by supporting multiple therapies with overlapping priorities and urgent requests
- Proven ability to quickly learn procedures and methods through providing regulatory support throughout registration process and life-cycle management of IND/(s)NDA/(s)BLA applications
- Takes initiative to look for opportunities for continuous improvement in collaborating across the organization with stakeholders to deliver efficiencies in regulatory submissions and processes
- Well organized and efficient in assembling, preparing, reviewing, and submitting original IND submissions, original registrations, amendments, supplements, and other regulatory documents to FDA in line with FDA requirements and guidelines
- Perform critical review and provide input to key submission and development documents (e.g
- Clinical and nonclinical summary documents, IBs, DSURs, PBRERs/PADERs, etc.) and demonstrate accountability and ownership by ensuring compliance with regulatory requirements
- Strong team player as the Regulatory representative on specific multi-discipline teams by providing regulatory guidance and strategy in working across organizational, functional, and geographic boundaries to achieve company goals
- Maintain current knowledge and continued awareness of FDA and ICH regulations, guidance documents and the regulatory competitive landscape and strong understanding of the regulatory submission and approval process.
Global Regulatory Affairs, Oncology (Regional Strategy)
Johnson & Johnson - Janssen Inc.
Raritan, NJ
09.2017 - 11.2019
- Regulatory Affairs Scientist
- Supported local operating companies (LOC) in the Asia Pacific (AP), Latin America (LA), Europe, the Middle East and Africa (EMEA) and Emerging Markets regions in the Oncology Therapeutic Area
- Liaised with clinical, labeling, CMC, dossier management, pharmacovigilance, and regional experts to assist these regions with country specific requirements (CSRs) necessary for pre-approval and post-approval Oncology product submissions
- Implemented the endorsed regional regulatory strategy and track the assembly of country-specific submission packages to the LOCs in accordance with endorsed global regulatory strategy
- Working knowledge of the Common Technical Document (CTD) structure and demonstrated experience with reviewing the dossiers (e.g
- Non-EU MAAs, iCTDs, MiCTDs, ACTDs) for registration submissions in both the eCTD and NeeS format
- Demonstrated leadership experience with generating, coordinating and delivering responses for registration Health Authority Queries (HAQs) and spontaneous HAQs in a timely manner and in line with product strategy
- Provided regulatory support for lifecycle management activities (e.g
- Renewal applications, labeling deviations, labeling updates, CMC Variations, PSURs/PBRERs, etc.) for both new and established Oncology products
- Assessed labeling discrepancies between local labels of AP, LA, EMEA, and Emerging Markets countries and company core data sheet (CCDS) to drive the resolution of labeling deviations
- Advised the Global Regulatory team (GRT) on local requirements and regional strategy
- Provided regulatory support for safety reporting (e.g
- PSUR/PBRER, SUSAR, etc.) and product complaints
- Contributed to regional regulatory process improvements through the creation of Best Practice Guides, Job Aids, Work Instructions, Trainings, etc.
R&D Quality – R&D Policies and Procedures
Bristol-Myers Squibb
Princeton, NJ
01.2016 - 04.2017
- CONTRACT Procedural Document Writer
- Wrote Procedural Documents for GCP, Regulatory and GMP processes – Study Start Up, Conduct and Execution, Protocol Development, Biospecimen Management, Financial Disclosure, Feasibility, Development of the Site Monitoring Plan, Investigator Meetings, Site Selection, Investigator Selection, Management of Investigational Medicinal Product (IMP), Managing IMP Recall or Withdrawal and Regulatory Submissions to Health Authorities (e.g
- NDAs, BLAs, Annual Reports, CTAs)
- Supported the R&D Breakthrough Simplification Initiative, an enterprise-wide initiative aimed at reducing complexity caused by the current governance and operating model for procedural documents
- Facilitated Sprint meetings, quarterly, off-site global meetings of Subject Matter Experts (SMEs) from various functional areas, to identify process-related risks and the controls to mitigate those risks to maintain global regulatory compliance
- Transformed procedural documents by incorporating the output from the SME meetings and using a principles-based writing model which focused on risk management and global regulatory compliance
- Managed and led procedural document review meetings with the SMEs to ensure the end-to-end process is captured and regulatory requirements are met.
Clinical Trial Management Office (CTMO) Internship
Covance Inc.
Princeton, NJ
06.2015 - 08.2015
- Utilized SharePoint to centralize and harmonize the data of several Clinical Trial Management high-priority initiatives including an SOP Management Project and a CAPA Management Project
- Provided analysis and facilitated an integrated tracking and reporting system for confirmed quality issues (CQIs), CAPAs, Sponsor Led ISAs, internal audits and client audits
- Established a framework to increase CAPA closure rates on time or ahead of schedule.
Upstream Process Development Internship
Bristol-Myers Squibb
Bloomsbury, NJ
06.2014 - 08.2014
- Developed a scale-down model using 24-deep well plates for Fed-Batch cultures to support a high throughput cell culture, improve mass transfer, and optimize mammalian cell growth
- Evaluated on-line monitoring of microwell plates for Fed-Batch suspension cultures of CHO cells
- Characterized the optimal conditions to support the growth of several clones of CHO cells in 24-deep well plates for the production of monoclonal antibodies.
Education
Master of Business and Science - Biotechnology & Genomics
Rutgers University, Graduate School
05.2016
Bachelor of Science - Biotechnology
Rutgers University, School of Environmental and Biological Sciences
05.2015
Skills
- Regulatory Strategy
- International Regulations
- Product Lifecycle Management
- Cross-Functional Team Leadership
- Compliance
- Negotiation
- Regulatory Filings
- FDA Regulations
- Policy Analysis
- Report Preparation
- Active Listening
- Flexible and Adaptable
Industry Courses
Regulatory Affairs Professionals Society (RAPS) - US Regulatory Affairs Certificate (RAC) Online Course, 07/2018, 07/2019, US RAC Pending
- The RAC US Online Course covers the four major domains included in the US RAC Exam – Strategic Planning, Pre-Approval, Approval and Post-Approval. The course is outlined to cover these four domains for the Biologics, Pharmaceuticals and Medical Devices and In Vitro Diagnostic Devices (IVDs) product areas and consists of 12 modules for each topic. The Practice US RAC Exam supplementary materials and guides are included.
Food and Drug Law Institute (FDLI) - Introduction to US Biologics and Biosimilars Law and Regulation, 10/2018
- This two-day course covered the regulation of biological products, including biotechnology derived therapeutic proteins, human tissue, gene, and cell products as well as the abbreviated pathway to market biosimilar biological products and the associated intellectual property issues and considerations, exclusivity and patent litigation. Concepts discussed include an overview of the organizational structure of the FDA and the impact on the Regulation of Biological Products, FDA Review and Approval of Biological Products, Biologics License Applications (BLAs) and abbreviated BLAs (ABLAs), Post-Approval Safety Issues, Regulation of Biological Manufacturing and Regulation of Biological Marketing.
Food and Drug Law Institute (FDLI) - Introduction to US Drug Law and Regulation, 04/2018
- This two-day course covered the essentials of US Drug Law and Regulation by providing a comprehensive understanding of the organizational structure of the FDA and the impact on the industry. Concepts discussed include an overview of the FDA’s regulatory process for drugs, New Drug Application Process (NDA): NDA Submission and Review, the Abbreviated NDA (ANDA), 505(b)(2) Applications, Patent and Exclusivity Issues, Biologics and the new regulatory pathway for Biosimilars, Post-approval drug safety issues, Advertising and promotion requirements, Regulation of Over-the-Counter (OTC) Drugs, Regulation of Drug Manufacturing and Drug Marketing.
Associations
- Regulatory Affairs Professionals Society (RAPS)
- Food and Drug Law Institute (FDLI)
- Association for GXP Excellence (AGXPE)
- Healthcare Businesswomen’s Association (HBA)
Publications
Evaluation of 24-Deep Well Plates for Accelerating Development of Fed-Batch Processes, Ping Xu, Nicole Dziedzic, Rosario Scott, 4th International Conference on Accelerating Biopharmaceutical Development (AIChE), 03/01/2015 - 03/04/2015, Scottsdale, Arizona, Characterized and compared the growth profile of CHO cells in 24-deep well plates and shake flasks to determine if the 24-deep well plates can be used as a reliable scale-down model for batch and fed-batch studies. The automation capability of 24-deep well plates has potential to accelerate the cell line selection and process development.
Activities
New Jersey School of Ballet, Livingston, NJ, 09/2005, 05/2015
Junior Company Ballet Dancer
- Performed various roles in NJB’s Nutcracker at the Paper Mill Playhouse, Sleeping Beauty, Cinderella, and Paquita., Traveled with the Company to perform the Nutcracker in Cape May and Bergen PAC., Participated at NJB’s Workshop performance at NJPAC., Received additional training at the Joffrey Ballet School in New York City.
Rutgers Ballroom Dance Team, New Brunswick, NJ, 09/2011, 05/2015
Team Member of the Rutgers Ballroom Dance Team
- Competed with the team at various competitions including the Princeton Ballroom Competition, Cornell Dancesport Classic, Rutgers Ballroom Competition, Big Apple Dancesport Challenge, and MIT Open Ballroom Dance Competition.
Timeline
Regulatory Advertising and Promotion (RAP) SHADOW
Johnson & Johnson
07.2023 - Current
Global Regulatory Affairs, Oncology, Cardiovascular & Metabolism (North America)
Johnson & Johnson - Janssen Inc.
11.2019 - Current
Global Regulatory Affairs, Oncology (Regional Strategy)
Johnson & Johnson - Janssen Inc.
09.2017 - 11.2019
R&D Quality – R&D Policies and Procedures
Bristol-Myers Squibb
01.2016 - 04.2017
Clinical Trial Management Office (CTMO) Internship
Covance Inc.
06.2015 - 08.2015
Upstream Process Development Internship
Bristol-Myers Squibb
06.2014 - 08.2014
Master of Business and Science - Biotechnology & Genomics
Rutgers University, Graduate School
Bachelor of Science - Biotechnology
Rutgers University, School of Environmental and Biological Sciences
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