As a Manager, Regulatory Affairs Advertising Promotion, you will be responsible for providing sound regulatory advice that minimizes the risk of regulatory and legal action, competitively positions assigned products and is consistent with applicable FDA regulations and GSK policies for advertising and promotion of prescription drug products and biologics.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...
* Provide Regulatory advice to Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the review and development of advertising and promotion for the US market in accordance with business goals and objectives, FDA regulation, PhRMA guidelines and company policy
* 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
* Manage interaction with OPDP, including response to regulatory inquiries, preparation of complete, accurate, high quality submissions for advisory comments, and as needed discussion with OPDP staff
* Participate in company working groups on advertising and promotion standards and guidelines
* Ensure that changes in US prescribing information are reflected in current promotion and advertising
* Understanding of labeling for assigned GSK and competitor products
* Competitively position promotional materials that comply with applicable FDA regulations, policies and guidance
* Demonstrate leadership as the Regulatory reviewer on copy approval teams such that recommendations are recognized as well-reasoned, valid and appropriate
* Monitor OPDP research, guidance and enforcement activities, assess impact and communicate learnings to stakeholders
* Influential member of multiple cross-functional US Pharma and R&D teams.
Competencies and Capabilities :
We are looking for professionals with these required skills to achieve our goals:
If you have the following characteristics, it would be a plus:
Our values and expectations are 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:
*This is a job description to aide in the job posting, but does not include all job evaluation details.
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