Intercept Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic liver diseases, such as primary biliary cirrhosis, utilizing our expertise in bile acid chemistry. Our product candidates have the potential to treat orphan and more prevalent liver diseases for which there currently are limited therapeutic solutions.
We are hiring a Director, Regulatory Affairs-Labeling and Promotions!
Manage and oversee regulatory review of materials related to labeling, advertising and promotion of all products reporting to the Vice President of Regulatory Affairs. Ensure compliance with internal SOPs and heath authority regulations, including compilation and submission of any required documents to regulatory agencies.
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
•Lead development and maintenance of global package inserts including USPI and SmPC to support regulatory submissions
•Maintain up-to-date knowledge of laws, regulations and policies enforced by the regulatory authorities as they relate to labeling, advertising and promotion of pharmaceuticals. Advise appropriate departments within the company of these requirements
•Develop and implement strategies to maintain efficient and compliant process for review of advertising/promotional materials and other labeling materials
•Review and submit advertising/promotional materials and other materials as required ensuring full regulatory compliance for all products
•Build strong relationships with internal customers; including Commercial, Legal and Clinical.
•Build strong relationships with regulatory authorities
•Bachelor’s degree in Biology or Chemistry, advanced degree preferred
•10 years of industry knowledge experience
(pharma, biotech, CRO).
•5+ years of regulatory experience.
•Minimum of 4 years regulatory promotional review.
•Experience providing direction to interdisciplinary teams on promotional materials and activities related to the launch of a new pharmaceutical product.
•Strong interest in the evolving landscape of FDA advertising and promotion regulations including FDA guidance(s).
•Proven ability to analyze and interpret efficacy and safety data.
REQUIRED KNOWLEDGE AND ABILITIES:
•Strong verbal and written communication skills are essential.
•Excellent organization and multi-tasking skills.
•Exceptional interpersonal skills and problem solving capabilities.
•Proven negotiation skills.
•Ability to work effectively across a matrix organization.
•Ability to work independently and prioritize with minimal daily instruction.
•Ability to think strategically in order to improve current processes.
TO APPLY: Email resume and cover letter to firstname.lastname@example.org. Please reference “Dir, RA-L&P” in the subject line. Only candidates with requisite experience will be considered. No phone calls or drop-ins.