AA2IT
Job ID: HCR0003126
Title: Regulatory Affairs Specialist
Location: Remote
Pay Rate: $45-80/hr
Contract Term: Six‑month contract (with intent to extend another six months)
Work Hours: 20 hours/week (Part‑time), Remote, Eastern or Frankfurt time zone
Standard Business Hours: Local to contractor, Tuesday‑Thursday (flexible)
The Advertising and Promotion Regulatory Affairs role provides strategic regulatory expertise and guidance to internal and external stakeholders related to the review of scientific information, advertising, promotional and other related materials for assigned products to ensure compliance with applicable regulations and guidance documents. The individual will represent regulatory on the PRC (Promotional Review Committee) team for assigned products and must possess thorough knowledge of regulations for advisement and promotional compliance across drugs, device and combination products. Experience reviewing promotional materials subject to both EU MDR and FDA regulations is required.
Major Duties
Material Review: Review and approve proposed advertising and promotional materials for multiple product lines.
Regulatory Awareness: Maintain current awareness of evolving EU MDR and FDA regulations, interpretations, enforcement letters and policy issues affecting the pharmaceutical and medical device industries.
Coordination of Promotional Review: Ensure adherence and compliance with the review and release process.
Guidance on Claims, ISI and Brief Summaries: Provide guidance and risk assessments on proposed claims for products in development and development of ISI (Important Safety Information) and Brief Summaries.
Creation of Launch Materials: Work closely with R&D project teams and marketing to advise on labeling and launch materials for new products and indications.
Management of Regulatory Support: Oversee timely and accurate submissions related to promotional materials as needed, support audits and health‑authority submissions.
Monitoring Regulatory Compliance Trends: Regularly monitor compliance trends in the aesthetic industry, interpret new regulations, guidance documents and enforcement actions.
Competitive Monitoring: Regularly monitor and advise on publicly available competitor materials to provide awareness and advice on current market trends and messaging.
Technical & Functional Skills
Strong knowledge of EU MDR and FDA regulations and guidance pertaining to drug and device advertising, promotion, and labeling.
Proficiency in Microsoft Outlook, Excel, PowerPoint and Word and comfort with a large variety of online meeting tools and AV equipment.
Excellent written, oral and interpersonal communication skills.
Demonstrated history of teamwork and cross‑functional collaboration.
Demonstrated history of creative problem solving and risk analysis related to promotional materials in the drug and medical device industry.
Minimum Qualifications
Bachelor's Degree – a 4‑year undergraduate degree in a scientific background (medicine, pharmaceutical sciences, human biology, or chemistry).
5+ years’ experience in regulatory drug and medical device promotion review.
Preferred Qualifications
Master's degree or higher in the above field is highly desirable.
Application Instructions
Q1:
How many years of exp in directly reviewing
advertising and promotional materials
for
drugs, devices, or combination products ?
Q2:
How many years of exp in reviewing promotional materials subject to
EU MDR
AND
FDA
advertising & promotion rules?
Q3:
How many years of exp in regulatory representative on PRC or equivalent review committees?
Q4:
How many years of exp in claim review, ISI (Important Safety Information), brief summaries, labeling, and launch materials?
Q5:
This is a fully remote part‑time position; how much salary you are presently getting and are you good to follow EST timezone?
#J-18808-Ljbffr
The Advertising and Promotion Regulatory Affairs role provides strategic regulatory expertise and guidance to internal and external stakeholders related to the review of scientific information, advertising, promotional and other related materials for assigned products to ensure compliance with applicable regulations and guidance documents. The individual will represent regulatory on the PRC (Promotional Review Committee) team for assigned products and must possess thorough knowledge of regulations for advisement and promotional compliance across drugs, device and combination products. Experience reviewing promotional materials subject to both EU MDR and FDA regulations is required.
Major Duties
Material Review: Review and approve proposed advertising and promotional materials for multiple product lines.
Regulatory Awareness: Maintain current awareness of evolving EU MDR and FDA regulations, interpretations, enforcement letters and policy issues affecting the pharmaceutical and medical device industries.
Coordination of Promotional Review: Ensure adherence and compliance with the review and release process.
Guidance on Claims, ISI and Brief Summaries: Provide guidance and risk assessments on proposed claims for products in development and development of ISI (Important Safety Information) and Brief Summaries.
Creation of Launch Materials: Work closely with R&D project teams and marketing to advise on labeling and launch materials for new products and indications.
Management of Regulatory Support: Oversee timely and accurate submissions related to promotional materials as needed, support audits and health‑authority submissions.
Monitoring Regulatory Compliance Trends: Regularly monitor compliance trends in the aesthetic industry, interpret new regulations, guidance documents and enforcement actions.
Competitive Monitoring: Regularly monitor and advise on publicly available competitor materials to provide awareness and advice on current market trends and messaging.
Technical & Functional Skills
Strong knowledge of EU MDR and FDA regulations and guidance pertaining to drug and device advertising, promotion, and labeling.
Proficiency in Microsoft Outlook, Excel, PowerPoint and Word and comfort with a large variety of online meeting tools and AV equipment.
Excellent written, oral and interpersonal communication skills.
Demonstrated history of teamwork and cross‑functional collaboration.
Demonstrated history of creative problem solving and risk analysis related to promotional materials in the drug and medical device industry.
Minimum Qualifications
Bachelor's Degree – a 4‑year undergraduate degree in a scientific background (medicine, pharmaceutical sciences, human biology, or chemistry).
5+ years’ experience in regulatory drug and medical device promotion review.
Preferred Qualifications
Master's degree or higher in the above field is highly desirable.
Application Instructions
Q1:
How many years of exp in directly reviewing
advertising and promotional materials
for
drugs, devices, or combination products ?
Q2:
How many years of exp in reviewing promotional materials subject to
EU MDR
AND
FDA
advertising & promotion rules?
Q3:
How many years of exp in regulatory representative on PRC or equivalent review committees?
Q4:
How many years of exp in claim review, ISI (Important Safety Information), brief summaries, labeling, and launch materials?
Q5:
This is a fully remote part‑time position; how much salary you are presently getting and are you good to follow EST timezone?
#J-18808-Ljbffr