Senior Director, Promotional Regulatory Affairs Us Lead
Current
Jul 2021 - Present
AeroLeads people directory · profile
Vera Makar Email & Phone Number
Senior Director, Promotional Regulatory Affairs US Lead
at
Jazz Pharmaceuticals
LinkedIn matched
✓ Verified Jun 2026
3 data sources
Profile completeness 86%
Current company
Role
Senior Director, Promotional Regulatory Affairs US Lead
Location
Ambler, Pennsylvania, United States
Who is Vera Makar? Overview
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Quick answer
Vera Makar is listed as Senior Director, Promotional Regulatory Affairs US Lead at Jazz Pharmaceuticals, based in Ambler, Pennsylvania, United States. AeroLeads shows a matched LinkedIn profile for Vera Makar.
Vera Makar previously worked as Director, Regulatory Advertising and Promotion at Johnson & Johnson and Regulatory Compliance Lead, Immunology at Johnson & Johnson. Vera Makar holds Ms, Quality Assurance, Regulatory Affairs from Temple University.
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Jazz Pharmaceuticals
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Profile bio
About Vera Makar
I consider myself a skilled Regulatory Affairs expert specializing in maximizing the effectiveness of Advertising and Promotion review teams within the pharmaceutical industry. I began my career with a smaller biotech startup, eventually advancing to lead the Ad/Promo compliance team at J&J, Janssen Immunology. As a visionary Team Leader, I excel in fostering symbiotic relationships with business partners, facilitating seamless communication, innovative problem-solving, and driving digital transformation.I've established multiple Promotional Review Committees, served as the primary contact for agencies, and obtained FDA approvals for multiple NDAs and INDs. With diverse experience across various therapeutic areas, I've supported numerous product launches and guided world-class brands to success.Currently, I serve as the head of US Promotional Regulatory Affairs at Jazz Pharmaceuticals. I am passionate about my work and take great pride in knowing that I've made a difference in the pharmaceutical industry. By combining my expertise, passion, and dedication, I've reached the pinnacle of my career, making meaningful contributions and establishing myself as a visionary leader in the field.
Current workplace
Vera Makar's current company
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7 roles · 25 years
Vera Makar work experience
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Director, Regulatory Advertising And Promotion
Jan 2016 - Aug 2021
Regulatory Compliance Lead, Immunology
Provides expert regulatory direction and oversight of advertising and promotion and marketing compliance related activities and serves as liaison to the OPDP for Dermatology, Rheumatology and GI product portfolio. Appointed “subject matter expert” within Ad/promo team for submitting materials for advisory comments for TV ads or new product launches. Solid.
Jan 2013 - Jan 2016
Sr. Manager, Promotional Regulatory Affairs
Primary responsible for regulatory advice, review and approval of advertising and promotion materials, sales training materials, scientific publications and corporate communications. Serve as the primary company contact with the FDA Office of Prescription Drug Promotion. Support various strategic initiatives to improve company's promotional regulatory.
Apr 2011 - Jan 2013
Manager, Regulatory Affairs
Cardiokine, Inc
Led submission team to prepare original IND eCTD-based submission in an expedited timeline. Prepared a working plan, and resolve issues early to avoid regulatory delays; identify complete information needed for the submission; Act as regulatory representative on product development teams; initiate and participate in the review of Investigator Brochures.
Mar 2008 - Jan 2011
Regulatory Affairs And Quality Assurance Associate
Prepare and submit correspondences and applications to FDA: IND,BLA and NDA Annual Product Reports, Distribution Reports, Drug Safety Reports, CBE/CBE30s, BPDRs;Review and track all AE, SAE; submit MEDWATCH FDA 3500A; Review, approve and release promotional materials and regulatory submissions, ensuring full compliance with all applicable FDA and FTC.
Aug 2004 - Mar 2008
Scientist
2001 - 2006
~5 yrs
2 education records
Vera Makar education
Ms, Quality Assurance, Regulatory Affairs
Temple University
Phd, Biophysics/Immunology
Russian Academy Of Sciense
FAQ
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What company does Vera Makar work for?
Vera Makar works for Jazz Pharmaceuticals.
What is Vera Makar's role at Jazz Pharmaceuticals?
Vera Makar is listed as Senior Director, Promotional Regulatory Affairs US Lead at Jazz Pharmaceuticals.
Where is Vera Makar based?
Vera Makar is based in Ambler, Pennsylvania, United States while working with Jazz Pharmaceuticals.
What companies has Vera Makar worked for?
Vera Makar has worked for Jazz Pharmaceuticals, Johnson & Johnson, Endo Pharmaceuticals, Cardiokine, Inc, and Cytogen Corporation.
How can I contact Vera Makar?
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What schools did Vera Makar attend?
Vera Makar holds Ms, Quality Assurance, Regulatory Affairs from Temple University.
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