Senior Regulatory Affairs Specialist - Ad/Promo

March 13

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

🌽 Illinois – Remote

Although this job is listed in Illinois, this company may be open to hiring remote in other states.

+6 more states

🏄 California – Remote 🌽 Illinois – Remote 🌲 North Carolina – Remote 🌲 Oregon – Remote 🦀 Maryland – Remote ❄️ Minnesota – Remote 🔔 Pennsylvania – Remote ☕ Washington – Remote

💵 $89k - $143.8k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Lifelancer

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Lifelancer is an AI-powered talent hiring platform that connects employers with skilled professionals in the Life Sciences, Pharmaceutical, and IT sectors. It enables individuals to create profiles showcasing their skills, get matched with high-paying international jobs or projects, and facilitates hiring and payroll for employers in multiple countries. The platform aims to streamline the hiring process with efficient AI sourcing and compliance support.

Life Science • Freelance • Remote Jobs • Healthcare • IT

51 - 200 employees

Founded 2020

🤖 Artificial Intelligence

🧬 Biotechnology

💊 Pharmaceuticals

💰 Pre Seed Round on 2022-03

📋 Description

• Collaboratively interface with marketing/sales personnel and other cross-functional departments and external entities, as applicable to review and provide guidance on advertising/promotion materials and messaging in compliance with SWMI commercial approvals and within established timelines. • Maintain geography specific advertising and promotion regulatory policies, processes and SOPs and train key internal stakeholders. • In collaboration with marketing personnel, assist RA leadership in establishing and maintaining product claims matrices for worldwide reference. • Conduct Regulatory advertising and promotional material reviews to ensure promotional, scientific, medical, and corporate external communications are compliant with applicable regulations, guidelines, corporate polices and business objectives. • Approve advertising and promotional materials to ensure compliance. • Ensure that changes in product labeling are appropriately reflected in current promotions and advertising. • Work collaboratively with the commercial team and any associated compliance functions to ensure that approved materials are used within the intended guidelines and duration of use. • Identify potential areas of regulatory compliance vulnerability and risk or opportunities for improvement; and develop/implement corrective action plans for resolution of problematic issues with guidance from RA leadership. • Identify and communicate emerging issues to RA leadership. • Plan and conduct meetings, create project plans and timelines, and manage projects with guidance from RA leadership, when assigned.

🎯 Requirements

• Minimum 5 years’ experience in a regulated healthcare industry with Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent experience. • Degree in science, math, engineering, medical or other technical fields and Class III medical device experience are preferred. • Minimum 1-2 years of experience completing regulatory affairs reviews of advertising and promotional related material in a medical device environment. • Advanced knowledge of FDA guidelines and regulations with an emphasis on product promotional activities. • Worldwide knowledge of advertising and promotional guidelines and regulations is a plus. • Ability to work accurately and collaboratively in a fast-paced environment while managing multiple priorities. • Apply effective communication skills, with the ability to convey messages in a logical and concise manner. • Ability to consistently reinforce regulatory expectations and requirements. • Think analytically with good problem solving skills. • Support and comply with the company’s Quality Management System policies and procedures. • Knowledge of business functions and cross group dependencies/ relationships. • Proficiency in MS Word, Excel and PowerPoint required.

🏖️ Benefits

• medical, dental, vision, life insurance • short- and long-term disability • business accident insurance • group legal insurance • consolidated retirement plan (pension) • savings plan (401(k)) • long-term incentive program • Vacation – up to 120 hours per calendar year • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year • Holiday pay, including Floating Holidays – up to 13 days per calendar year • Work, Personal and Family Time - up to 40 hours per calendar year