Title: Regulatory Affairs Advertising and Promotion Specialist
Location: Edison, NJ/Remote
If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE AND REGION within the subject line.
The Regulatory Affairs Advertising and Promotion Specialist, under general guidance, prepares, reviews, and submits high quality submissions of promotional materials to FDA during the pre- and post-marketing phases, within company timelines and in accordance with regulatory guidelines. This role will work cross-functionally with marketing operations, clinical regulatory, and external partners. In addition, this role will support the Legal function with contract management.
Responsibilities include but are not limited to:
––Coordinate submission of promotional materials to the Office of Prescription Drug Promotion
––Support building out internal regulatory publishing capabilities for LCM submissions
––Work in partnership with MLR manager and other business partners to identify communication gaps and opportunities for training on the regulatory requirements for quality submissions
––Assist in the review of labeling and marketing materials for regulatory guidance
––Support the Legal function with management of contracts from initial request to full execution
––Provide support to assigned products and projects in the Office of General Counsel
––With support, keep current in the areas of regulatory, healthcare compliance and ethics
––Communicate significant changes or other relevant matters to internal partners and stakeholders
––At least one year of experience working in research or database management OR three months total of industry internships (may including part time work while in school)
––Experienced with proofreading technical documents. Attention to detail is critical for this job.
––Strong interpersonal skills, with the ability to work collaboratively across functions
––Demonstrates process-orientation, with the ability to think through required steps and sequencing to ensure quality work output
––Must demonstrate knowledge of, or the aptitude to learn, the legal and regulatory environment as it relates to healthcare compliance in the bio/pharma industry
––Familiarity with US regulations, regulatory guidance/guidelines, eCTD or XML, Veeva or basic therapeutic knowledge and understanding of clinical development preferred
Bachelor’s Degree in Biology, Chemistry, Law, Logic or related field. Advanced degree (MS, PhD or PharmD) completed in the past two years preferred