Zina Manji, M.S., PharmD

Co-Founder

Washington, DC, United States28 yrs 5 mos experience

Key Highlights

  • Expert in regulatory strategy for healthcare innovation.
  • Speaker at prominent digital health symposia.
  • Leader in value-based healthcare transformation.
Stackforce AI infers this person is a Healthcare Regulatory Affairs Expert with a focus on innovation and digital health strategies.

Contact

Skills

Other Skills

Regulatory AffairsRegulatory SubmissionsMedical DevicesR&DPharmaceutical IndustryDrug DevelopmentFDAClinical TrialsINDRegulatory RequirementseCTDClinical DevelopmentPharmacovigilancePharmaceuticsSop

About

I’m a regulatory strategist for innovation, an entrepreneur - identifying and creating synergy: regulatory strategy + innovation for healthcare solutions that deliver meaningful health outcomes and empower individuals to live well. Some of my insights: - Innovations shape regulations - Innovation is the driver towards value-based healthcare - Convergence of technologies and delivery models enables improvement of health outcomes - Data [clinical evidence] is an asset, not a cost: business case should maximize these assets. - The absence of a method to valuate data doesn’t mean there’s an absence of value - Think beyond the product, what is the product in service of, what outcome? - An innovation strategy based on an “infinite” mindset can enable disruptive innovation to come to life Engaged global regulatory affairs leader experienced in developing high performing teams providing end-to-end strategies and R&D value creation for global brands and disruptive innovations. Relentlessly seeking to unlock regulatory pathways to improve health outcomes. HITLAB Digital Health Symposia speaker & contributor Columbia Business School Exec Ed Digital Health program series guest speaker Member: DiME (Digital Medicine Society) HealthXL Previous NYCHBL (New York City Health Business Leaders) now DHNY member (Digital Health New York) HealthXL participant and guest moderator #emergingscience #regulatoryaffairs #selfcare #digitalhealth #convergingtechnologies #precisionmedicine #diagnostics #disruptivestrategy #disruptiveinnovation #healthcareisselfcare #digitaltransformation

Experience

Women's health advocates

Steering Committee Member

Aug 2025Present · 7 mos

  • Women’s Health is Human Health.
  • WHA advocate and steering committee member.
  • Volunteer

Innopathwayz, llc

2 roles

Podcast Host

Apr 2025Present · 11 mos

  • IPZO facto, Innovation: No Way But Forward
  • YouTube podcast @INNOPATHWAYZ
  • Also available on Apple Podcast, Spotify and more.

Founder & Principal, Regulatory Strategist

Mar 2024Present · 2 yrs

  • Regulatory affairs and innovation strategy consulting.

Extendhealth consultants inc.

Regulatory Strategy Partner

Mar 2024Present · 2 yrs

Ellume

VP of Regulatory Affairs

May 2023Jan 2024 · 8 mos · United States

  • Head of N.Am Regulatory Affairs (May), VP of Regulatory Affairs (June). Digital diagnostics, medical device, IVD, EUA, lifecycle management, DeNovo and 510(k) pipeline review, plus co-development - partnerships evaluations and strategies.

Hitlab

Global Fellow

Apr 2023Jun 2025 · 2 yrs 2 mos · New York City Metropolitan Area

  • Digital Health, Healthcare Innovation,
  • Breakthrough One global member,
  • HITLAB Symposia virtual series presenter: monthly segments titled “Digital Health Focus”, Breakthrough Alliance challenge judge, Innovators Summit keynote speaker

Haleon

Sr. Director Regulatory Affairs Lead - Innovation, US

Jul 2022Apr 2023 · 9 mos · Warren, New Jersey, United States

  • GSK Consumer Healthcare demerger July 18, 2022

Gsk

7 roles

Sr Director, Regulatory Affairs Lead - Innovation, US

Mar 2020Jul 2022 · 2 yrs 4 mos

  • GSK Consumer Healthcare

Sr Director, Global Regulatory Affairs, Emerging Science Innovation

Nov 2017Mar 2020 · 2 yrs 4 mos

  • GSK Consumer Healthcare

Sr Director, Global Regulatory Affairs, Skin Health

Promoted

Apr 2013Nov 2017 · 4 yrs 7 mos

  • GSK Consumer Healthcare

Director Global Regulatory Affairs, Pain Management, Smoking Cessation, Breathe Right (brand)

Promoted

Oct 2007Apr 2013 · 5 yrs 6 mos

  • GSK Consumer Healthcare

Regulatory Affairs Manager to Assistant Director, Nicorette (promoted 2005)

Promoted

May 2004Oct 2007 · 3 yrs 5 mos

  • GSK Consumer Healthcare

Regulatory Affairs Associate, GI, Denture Care and Wellness areas, Global and US market

Oct 2000May 2004 · 3 yrs 7 mos

  • GSK Consumer Healthcare

Intern, Research & Development: GI and VMS

Mar 2000Oct 2000 · 7 mos

  • GSK Consumer Healthcare
  • (joined as SmithKline Beecham). Publication: Bendich, A. Calcium Supplementation and Iron Status of Females. Nutrition 17:46-51, 2001 (Acknowledgement)

The national institutes of health

Graduate Intern, gender differences in pharmacology. ORWH, Office of Research on Women's Health

Jun 1999Aug 1999 · 2 mos · Washington D.C. Metro Area

  • Researched literature and developed library database on differences in the ways in which women and men respond to pharmacologic agents

University of iowa

3 roles

Planning Committee, International Women's Health Conference

Jan 1999Mar 1999 · 2 mos · Iowa City, Iowa Area

Research Assistant, Pharmacist. Drug Information, Iowa Drug Information Service (IDIS)

Jun 1997May 1999 · 1 yr 11 mos · Iowa City, Iowa Area

Graduate Teaching Assistant, Drug Information. College of Pharmacy

Jan 1997May 1998 · 1 yr 4 mos · Iowa City, Iowa Area

The national institutes of health

Rapporteur: NIH Women's Health Research Agenda for the 21st Century

Jul 1997Oct 1997 · 3 mos · Santa Fe, New Mexico Area

  • Report published: Differences Among Populations of Women: Reproductive and Middle years, D. Krotoski, J. Silliman, Z. Manji, in a Report of the Task Force on the NIH Women's Health Research Agenda for the 21st Century, Volume 6, July 1997.

Education

Harvard Business School Online

Certificate — Disruptive Strategy with Clayton Christensen

Jan 2019Jan 2019

Columbia Business School

Certificates (Columbia Executive Education)

Jan 2020Jan 2020

Columbia Business School

Certificate in Business Excellence with focus on Digital Health (Columbia Executive Education)

Feb 2021Present

Northwestern University - Kellogg School of Management

RAPS Executive Development Program

Jan 2014Jan 2014

University of Iowa

Master of Science - MS — Clinical Pharmacy

University of Iowa

Doctor of Pharmacy - PharmD

University of Iowa

Bachelor of Science - BS — Pharmacy

Stackforce found 100+ more professionals with Regulatory Affairs & Regulatory Submissions

Explore similar profiles based on matching skills and experience