Regulatory Advertising and Promotion Policy Associate Director
Philadelphia, Pennsylvania; Waltham, Massachusetts; Research
Triangle Park, North Carolina
Are you interested in providing sound regulatory advice that is
consistent with applicable FDA regulations and GSK policies for
advertising and promotion of prescription drug products and
biologics, while competitively positioning assigned products? If
so, the Regulatory Advertising & Promotion Policy role may be ideal
for you to explore.
As a Regulatory Advertising & Promotion Policy Associate
Director, you will have the opportunity to:
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
Provide leadership on copy approval teams such that
recommendations are recognized as well-reasoned, valid and
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
Ensure application of key learnings across assigned brands
Recommend appropriate actions for proposed advertising and
promotion with established precedent
This role will provide YOU the opportunity to lead key
activities to progress YOUR career. These responsibilities include
some of the following :
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
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
Why you? Basic Qualifications: We are looking for professionals
with these required skills to achieve our goals:
Undergraduate degree in a biological or health care scientific
2-5 years of experience in pharmaceutical/biologics regulatory,
or scientific disciplines
1-2 years in the review of prescription drug adverting and
Preferred Qualifications: If you have the following
characteristics it would be a plus:
Be able to demonstrate strategic and analytical thinking
Demonstrated success in constructive contributions to
multidiscipline matrix teams.
Demonstrated ability to facilitate appropriate team
Advanced degree in biological or health care scientific
5 -10 years of experience in pharmaceutical/biologics
regulatory, or scientific disciplines
2-5 years in the review of prescription drug adverting and
promotion for compliance with applicable FDA laws, regulations and
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
Why GSK? Our values and expectationsare at the heart of
everything we do and form an important part of our culture. These
include Patient focus, Transparency, Respect, Integrity along with
Courage, Accountability, Development, and Teamwork. As GSK focuses
on our values and expectations and a culture of innovation,
performance, and trust, the successful candidate will demonstrate
the following capabilities:
Operating at pace and agile decision-making – using evidence and
applying judgement to balance pace, rigour and risk.
Committed to delivering high quality results, overcoming
challenges, focusing on what matters, execution.
Continuously looking for opportunities to learn, build skills
and share learning.
Sustaining energy and well-being.
Building strong relationships and collaboration, honest and open
Budgeting and cost-consciousness.
If you require an accommodation or other assistance to apply for
a job at GSK, please contact the GSK Service Centre at
1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere
to Affirmative Action principles. This ensures that 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.
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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
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information, please visit GSK’s Transparency Reporting For the
Regulatory Advertising and Promotion Policy Associate Director
Full-Time, Philadelphia, Pennsylvania, United States Regulatory
Advertising and Promotion Policy Associate Director Full-Time,
Philadelphia, Pennsylvania, United States Start a career with
purpose GSK is a place where outstanding people do amazing things.
As a science-led global healthcare company, we exist to help people
do more, feel better, live longer.
Annual bonus based on company performance
Long term incentives and pension plan
Learning and career development
Access to healthcare & wellbeing programmes