US & Global Regulatory Affairs

NISHA PARIKH, PHARMD, MBAC

***** ********** *****, *******, ** 20854 • PHONE 240-***-**** • E-MAIL **********@*****.*** SUMMARY

A results-driven, solutions-oriented, patient-centric regulatory professional with NDA, ANDA, and Monograph experience seeking to advance into a managerial role to drive strategy for key business initiatives, implement action, and broaden professional growth Dynamic,

Transferable Skillset

Leading in

ambiguity

Insights-driven

urgency

Developing others

in complexity

Analytic, idea-generating,

proactive mindset

Shaping regulatory

strategy

PROFESSIONAL EXPERIENCES

Senior Associate, US & Global Regulatory Affairs July 2017 – Present Johnson & Johnson Consumer Inc., Fort Washington, PA Lead strategic efforts across the Allergy, Eye Care, and Upper Respiratory portfolios, a $4.2B OTC business in a $13.6B total consumer market, spanning 7 new product launches, advertising and promotion strategies, lifecycle management, and external public-private partnerships Daily responsibilities include:

• Serve as the North American liaison for coordinating, collecting, assessing, and reporting health authority-driven and local-driven spontaneous queries and regulatory standards monitoring to successfully support all safety-related responsibilities and remain in compliance with regulatory procedures

• Deliver strategic insight and provide actionable recommendations for the Allergy, Eye Care, and Upper Respiratory businesses, as the lead regulatory reviewer for US advertising, promotional and labeling materials, supporting both marketed and new product launches

• Interact with regulatory agency personnel to seek guidance, expedite approval of pending applications and resolve regulatory matters for NDA/ANDA products to enable competitive initiatives, meet critical launch deadlines and ensure compliance in all actions

• Represent J&J in strategic discussions with CHPA (trade association) and industry stakeholders to shape external policy, support key regulatory deliverables, and lead budget conversations for task groups to prioritize base business requirements and facilitate growth

• Present the key milestones, competitive landscape, regulatory-driven initiatives, and strategically ranked upcoming deliverables for the Eye Care franchise in quarterly New Product Development forums to US, Canada and EMEA senior leaders and management

• Drive local and global regulatory initiatives and strategies for high-volume projects in response to innovation, claims development, product labeling change controls, registration dates, and product safety and compliance to support key regulatory imperatives

• Complete and monitor Company Core Data Sheet (CCDS) validation forms to assess and resolve discrepancies identified between clinical support and the local drug facts label to protect consumer safety and proactively meet core business safety objectives

• Precept, enhance and retain talent by providing day-to-day support, guidance and influential mentorship to the J&J Consumer Regulatory Affairs Fellowship program, Cristo Rey High School Work Study program, Big Brother Big Sister Mentoring program, and cross-sector Global Regulatory Affairs Internship program

• Shape and expand Employee Resource Group (ERG) objectives through leadership roles and involvement to successfully drive key company initiatives and member encouragement (i.e. Diversity and Inclusion, Championing Women, New Employee Support) Key accomplishments include:

• Led and drove the development of the electronic common technical document (eCTD) Global Dossier for a Visine® submission under expedited timelines to successfully support the reformulation and re-launch of two products, interact with global partners to align on all regional requirements, and target key registration dates in the US, EMEA, APAC, LATAM, and Canadian markets

• Participated in a two-week, cross-functional business ‘SWAT’ team to provide accelerated “on-call” regulatory support for a monograph drug labeling imperative, reducing the average beginning-to-end deliverable and resolution time by more than 50% the expected timeline through improved process mapping, eliminated redundancies, clarified responsibilities, and maximized collaboration

• Partnered with senior leadership, key opinion leaders, therapeutic experts, specialty physicians, and health authority personnel in an Advisory Committee Meeting to brainstorm competitive tactics and regulatory strategies for an innovative Rx to OTC switch

• Adapted to evolving business needs by providing in-depth regulatory support for successful innovation and development initiatives: new product reformulation, improved brand architecture and packaging design, claim differentiation, and brand positioning

• Represented J&J at key meetings and through various platforms: submitted and presented a poster on the “Regulatory Strategy in the Consumer Sector: Every Regulatory Classification” at the 2017 J&J SHINE Summit at Ethicon, Inc. and facilitated discussions with cross-sector professionals surrounding OTC monograph drugs vs. NDA drugs and the RX to OTC switch process Post-Doctoral Fellow, US Regulatory Affairs & Medical Information July 2016 – June 2017 Johnson & Johnson Consumer Inc., Fort Washington, PA Regulatory Affairs Lead for support to marketed products in the Digestive Health, Pain, and Allergy need states by being nimble in an evolving, multi-dimensional, competitive, regulatory, strategic, and legal landscape. Key Regulatory Affairs responsibilities include:

• Headed the Digestive Health initiative to restructure the Lactaid® portfolio, refocus labeling elements based on Code of Federal Regulation insights, and leverage knowledge of key changes in the regulatory environment to ensure compliance and competitiveness

• Served as the regulatory contact for monitoring and tracking relevant product safety signals and adverse event reporting to provide quarterly updates to senior leadership, assess the impact of the signal, and assist in strategizing the best path forward for resolution

• Prepared internal regulatory slide decks, posters and situation analysis spreadsheets for the Senior Director of Regulatory Affairs, using proficient PowerPoint and Excel skills, to facilitate key presentations in Quarterly R&D Town Hall and Leadership Board meetings Nisha Parikh

Curriculum Vitae

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• Re-shaped the regulatory-driven dosing cup model by streamlining extraneous measurement lines to align with product labeling and dosing directions across the brands, implementing volumetric dosing cups to ensure ingestion accuracy and developing standardized consumer care center responses, significantly cutting business expenses for dosing cup production and improving product delivery

• Launched new monthly article series to share critical and educational OTC regulatory updates in the Global R&D Newsletter by consulting with key individuals in the organization, consolidating a high-volume of information, and executing professional writing

• Reviewed and approved artwork, principal display panels, drug facts information, and promotional copy material to ensure regulatory compliance, verify scientific accuracy and support business initiatives for the Digestive Health, Pain, and Allergy franchises

• Supported the development and approval of critical labeling source documents (manuscript, labeling information sheet, master formula record, cation assessment) to distribute among relevant cross-functional partners, provide feedback, and facilitate the labeling process

• Developed and revised internal safety documents including the Ascorbic Acid Company Core Data Sheet (CCDS) and various Child Resistant Packaging (CRP) standards to assist in strategizing best practices

• Supported key brands and gained exposure to products of various regulatory classifications (dietary supplements, NDA, ANDA, IND, monograph drugs, and medical devices)

Key Medical Information responsibilities include:

• Improved current practices for approving promotional materials by driving the regulatory and R&D initiative to develop an electronic claims database for the claims center of excellence (COE) in order to recognize gaps in current efficiencies, strategize manageable methods of adapting to evolving business needs, and implement increased productivity for the consumer space

• Collected, prepared, and disseminated medical information via thorough literature searches to internal and external stakeholders upon request for the Digestive Health, Pain, and Allergy franchises

• Authored standard and non-standard response letters in both written or oral communication in response to inquiries from healthcare professionals, consumers, and sales representatives

• Established and presented PowerPoint deliverables regarding medical education and competitive intelligence to both the sales and marketing teams

Advanced Pharmacy Practice Experiential Extern September 2015 – October 2015 US Food and Drug Administration (FDA), CDER Office of Compliance, Silver Spring, MD

• Created and submitted deficiency letters after reviewing product reports against the Orange Book database, given the National Drug Code (NDC) and application numbers, to resolve discrepancies within compliance cases submitted by various pharmaceuticals

• Represented the electronic Drug Listing and Registration division at a National Library of Medicine Structured Product Labeling Conference and presented key takeaways, direction on future submissions, and current system implications to the FDA team

• Participated in professional seminars on orphan drug development, public health services, medical literature search tools, and new drug approval processes, and attended tours at United States Pharmacopeia, The Pentagon, and American Pharmacists Association (APhA) EDUCATION

Master of Business Administration in Pharmaceutical and Healthcare Business Anticipated: August 2018 University of the Sciences, Mayes College of Healthcare Business and Policy, Philadelphia, PA Doctor of Pharmacy May 2016

Minor in Pharmaceutical and Healthcare Business

University of the Sciences, Philadelphia College of Pharmacy, Philadelphia, PA Bachelor of Science in Pharmaceutical and Healthcare Studies May 2014 University of the Sciences, Philadelphia College of Pharmacy, Philadelphia, PA HONORS AND AWARDS

Gold Encore Award, Johnson & Johnson Consumer Inc. March 2018 Driving and participating in urgent labeling ‘SWAT’ collaboration – CONNECT, LEAD, SHAPE, and DELIVER Leadership Imperatives Gold Encore Award, Johnson & Johnson Consumer Inc. February 2018 Leading and coordinating development of the Visine Project Pool Global Dossier – CONNECT and LEAD Leadership Imperatives Delta Mu Delta International Business Honor Society, Xi Lambda Chapter, University of the Sciences February 2018 Supports academic achievement: Top 20% of Graduate class; Inducted by Accreditation Council for Business Schools and Programs LEADERSHIP

Networking and Outreach Chapter Lead January 2018 – Present External Outreach Chapter Lead July 2017 – January 2018 J&J Site Lead for Supporting and Helping the Integration of New Employees (SHINE) Employee Resource Group Member Engagement Chapter Lead January 2018 – Present J&J Site Lead for Women’s Leadership and Inclusion (WLI) Employee Resource Group Nisha Parikh

Curriculum Vitae

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Mentor/Supervisor

Global Regulatory Affairs Summer Internship Program February 2018 – Present J&J Cristo Rey High School Work Study Program July 2017 – Present J&J Consumer Inc. & University of the Sciences Fellowship Program July 2017 – Present J&J Big Brother Big Sister ‘Beyond School Walls’ Mentorship Program July 2016 – Present Clinical Instructor of Pharmacy Practice and Pharmacy Administration July 2016 – May 2017 Adjunct faculty for 35 students in core courses ‘Drug Information and Literature Evaluation’ and ‘Seminar’ at the University of the Sciences PRESENTATIONS AND RESEARCH EXPERIENCE

Parikh, N. (2018, January). Introduction and strategic importance of regulatory affairs: Monograph, NDA, ANDA, IND, 510K. Guest lecturer for ‘Introduction to Industry’ course, University of the Sciences. Kline, T., Parikh, N. (2017, October). Regulatory strategy in the consumer sector: every regulatory classification. Poster selected and presented at the J&J SHINE Summit, Ethicon Inc.

Parikh, N., Mandler H. (2017, May). Evaluating pharmacists’ criteria for recommending over-the-counter intranasal corticosteroids for pediatric patients. Poster presented at Research Day, University of the Sciences. Parikh, N. (2017, April). Pharmacist prescribing of hormonal contraceptives: regulatory and controversial impact. 1-credit hour Continuing Education (CE) topic, presented at the annual Pharmacists’ Network Meeting and Industry Day, Janssen Inc. Parikh, N. (2017, April). Zyrtec® and the impact on ocular effects. Sales Team Presentation, Johnson & Johnson Consumer Inc. PROFESSIONAL AND CLERKSHIP PHARMACY EXPERIENCES

Giant Pharmacy Poison Control Center Drug Information Association (DIA) Acro Pharmaceutical Services (Specialty) Mercy Philadelphia Hospital Walter Reed Medical Military Center Johns Hopkins Hospital, Surgical ICU Indian Health Service (IHS) Blair Pharmaceutical Research, UPenn LICENSES AND CERTIFICATIONS

Academic Teaching Certificate June 2017 – Present

APhA Pharmacy-Based Immunization Delivery Certificate May 2015 – Present CPR/First-Aid/AED Life Support Certification February 2015 – Present PROFESSIONAL AFFILIATIONS

Pharmacists’ Network American Society of Health-Systems Pharmacists (ASHP) Industry Pharmacists Organization (IPhO) American Pharmacists Association (APhA) Drug Information Association (DIA) Delta Mu Delta International Business Honor Society

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