Regulatory Advertising and Promotion Policy, Manager

Basic qualifications:

  • Undergraduate degree in a biological, legal or health care scientific discipline
  • 3-5 years of experience in pharmaceutical/biologics regulatory, or scientific disciplines
  • 1-2 years in the review of prescription drug adverting and promotion for compliance with applicable FDA laws, regulations and guidance documents.
  • Be able to demonstrate strategic and analytical thinking
  • Demonstrated success in constructive contributions to multidiscipline matrix teams.
  • Demonstrated ability to facilitate appropriate team decisions.

Preferred qualifications:

  • Advanced degree in biological or health care scientific discipline
  • 5 -10 years of experience in pharmaceutical/biologics regulatory, or scientific disciplines
  • 3-5 years in the review of prescription drug adverting and promotion for compliance with applicable FDA laws, regulations and guidance documents
  • Demonstrable history of successful interactions with FDA reviewers at OPDP.
  • Understanding of product development process, including clinical trial design, and labeling development process
  • Proven ability to multi task and excel in cross functional settings and to manage multiple projects in a fast paced environment


This role is equivalent to an Associate Director.


  • Competitively position promotional materials that comply with applicable FDA and corporate regulations, policies and guidance
  • Serve as internal expert on FDA regulations governing the promotion of assigned products.
  • Act as a credible, influential, respected spokesperson during interactions with the Office of Prescription Drug Promotion (OPDP) reviewers for assigned products
  • Establish and nurture a productive, transparent relationship with OPDP to achieve successful and timely review of advisory submissions and effective resolution of regulatory actions.
  • Manage interaction with OPDP including response to regulatory inquiries or enforcement actions, preparation of complete, accurate, high quality submissions for advisory comments, and discussion with OPDP staff on requested changes.
  • Appropriate, proactive communications with OPDP reviewers that help ensure expedient and efficient review of regulatory submissions
  • Leadership on copy approval teams such that recommendations are recognized as well-reasoned, valid and appropriate
  • Ensure all submissions to OPDP are complete, accurate, of high quality, in regulatory compliance and presented in a manner that facilitates agency review.
  • Monitor OPDP activities and actions, assesses impact and communicates information to stakeholders.
  • Advise on the development of US labeling to ensure support for anticipated promotional messages and claims.
  • Influential member of multiple cross-functional US Pharma and R&D teams with junior and some senior membership
  • Analyze whether non-clinical promotional claims are supported
  • Ensure application of key learnings across assigned brands
  • Recommend appropriate actions for proposed advertising and promotion with established precedent


  • Provides operational leadership to Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the development of in advertising and promotion for the US market (for minor company assets) in accordance with business goals and objectives, FDA regulation, ICH guidelines, PhRMA guidelines and company policy
  • Effective communications with reviewers within OPDP that expedite resolution of issues relating to assigned products
  • Understanding of labeling for assigned GSK and competitor products
  • Ensure that changes in US prescribing information are reflected in current promotion and advertising
  • Participate in company working groups on advertising and promotion standards and guidelines
  • Maintain a quality system to support advertising and promotion regulatory requirements

Deadline for Applications: 28th September 2017

Contact information:

You may apply for this position online by selecting the Apply now button.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Meet Some of GlaxoSmithKline's Employees


Procurement Associate

Jasdeep finds diverse suppliers to build GSK’s pipeline. He organizes joint ventures with companies and negotiates pricing rates and payments to build a seamless supply system for GSK’s materials and products.


HR Associate, Future Leaders Program

Now in her second rotation of GSK’s Human Resources Future Leaders Programme, Andrea is shaping the future of talent management within Research and Development, from workforce assessments to strategy and operations.

Back to top