Our client is a biopharmaceutical company. They have asked us to assist them in their search for a Director Regulatory Affairs, Advertising & Promotional Review.
Major tasks and responsibilities will include:
Conducts the regulatory review of advertising and promotional materials for assigned products.
Ensures compliance with applicable FDA and EU laws, regulations, and guidance.
Serves as primary contact with the FDA Office of Prescription Drug Promotion (OPDP) for assigned products.
Provides regulatory expertise and guidance within a collaborative cross-functional team.
Ensures that there is labeling input in the implementation of regulatory strategies.
Formulates regulatory labeling strategies for implementation of new and revised prescribing information and packaging.
Reviews and approves Form FDA-2253 submissions to OPDP.
Interprets scientific and clinical data and leads development of labeling to optimize product potential and patient benefit-risk ratio.
Maintains awareness of regulatory legislation pertaining to labeling. Assesses and communicates impact on the company and its products.
We seek candidates with the following qualifications:
Bachelors degree in a related field required.
Must have 7+ years of pharmaceutical industry experience as a regulatory reviewer of advertising and promotional materials.
Requires strong knowledge of Global regulations and their interpretation relevant to prescription drug advertising, promotion, and labeling.
Commercial launch and advisory comment process experience highly preferred.
Must have working knowledge of the drug development process, including labeling development process.
Requires understanding of XML and Electronic Document Management Systems to a sufficient level to support labeling documentation.
If interested, please email your resume as a Word attachment to us, reference 3771. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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