Vera Makar Email and Phone Number
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.
-
Senior Director, Promotional Regulatory Affairs Us LeadJazz Pharmaceuticals Jul 2021 - PresentDublin, Ie
-
Director, Regulatory Advertising And PromotionJohnson & Johnson Jan 2016 - Aug 2021New Brunswick, Nj, Us -
Regulatory Compliance Lead, ImmunologyJohnson & Johnson Jan 2013 - Jan 2016New Brunswick, Nj, UsProvides 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 experience communicating and negotiating directly with OPDP. Demonstrated ability to successfully lead and coach project teams; train, mentor and influence at multiple levels of management.
-
Sr. Manager, Promotional Regulatory AffairsEndo Pharmaceuticals Apr 2011 - Jan 2013Malvern, Pa, UsPrimary 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 compliance; brand teams suport during development of marketing campaigns for new products/new indications. -
Manager, Regulatory AffairsCardiokine, Inc Mar 2008 - Jan 2011Led 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, non-clinical reports, clinical protocols, CMC and IND/NDA submissions; Assemble, review, and file IND amendments and manage all IND maintenance activities, independently prepare and submit annual reports and periodic safety reports; Coordinate NDA submissions preparation: work with contractors to prepare scoping document for the submission. Assist with mapping to the CTD and using/customizing of templates; Manage FDA liaison for assigned development projects
-
Regulatory Affairs And Quality Assurance AssociateCytogen Corporation Aug 2004 - Mar 2008UsPrepare 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 regulations and industry guidelines; Assist in responses to inspection findings and warning letters; Ensure product safety by reviewing batch records results according to manufacturer’s specifications and internally determined criteria; Prepare and conduct internal and external audit, covering all aspects of the Quality System and promote an environment of compliance, safety and integrity of the final product. -
ScientistTemple University 2001 - 2006Philadelphia, Pennsylvania, Us
Vera Makar Education Details
-
Temple UniversityRegulatory Affairs -
Russian Academy Of ScienseBiophysics/Immunology
Frequently Asked Questions about Vera Makar
What company does Vera Makar work for?
Vera Makar works for Jazz Pharmaceuticals
What is Vera Makar's role at the current company?
Vera Makar's current role is Senior Director, Promotional Regulatory Affairs US Lead.
What schools did Vera Makar attend?
Vera Makar attended Temple University, Russian Academy Of Sciense.
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial