Consultant II

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🔥 6 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

💼 Consultant

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Syner-G BioPharma Group

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Syner-G BioPharma Group is the world's leading provider of chemistry, manufacturing and controls (CMC), regulatory affairs, and medical writing solutions for the biopharma sector. They offer comprehensive services that navigate clients through the complexities of pharmaceutical development, regulatory submissions, and quality compliance, ensuring high-quality outcomes. With a multidisciplinary team, Syner-G integrates science, engineering, and regulatory expertise to support drug development from pre-IND to post-approval phases, enabling timely submissions and patient safety adherence.

📋 Description

• Ensure promotional communications are truthful, balanced, non-misleading, evidence-based, and consistent with approved product labeling, applicable FDA requirements, OPDP expectations, Health Canada regulations, and PAAB Code standards. • Serve as a key regulatory partner to Commercial, Medical, Legal, and Global Regulatory teams. • Lead regulatory review and risk assessment activities for US and Canadian promotional materials directed to stakeholders. • Evaluate materials for consistency with approved labeling, scientific evidence, fair balance requirements, risk communication, and overall regulatory compliance. • Conduct risk assessments and provide recommendations supporting compliant and effective stakeholder communications. • Collaborate with internal stakeholders and external agencies to resolve regulatory comments and ensure alignment on promotional strategy. • Provide strategic guidance regarding FDA and OPDP requirements for prescription drug advertising, promotional labeling, product claims, risk communication, and submission readiness. • Support promotional strategy for product launches, lifecycle management activities, label changes, and new indications.

🎯 Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline required. • Advanced degree preferred. • Minimum 3-5 years of experience within the pharmaceutical, biotechnology, biologics, biosimilars, regulatory, or health authority environment. • Significant experience in advertising and promotional regulatory review. • Experience participating in multidisciplinary Medical/Legal/Regulatory (MLR) review processes. • Demonstrated ability to influence cross-functional teams while maintaining regulatory integrity. • Strong knowledge of FDA promotional requirements and OPDP expectations governing prescription drug advertising and promotional labeling. • Strong understanding of Health Canada advertising requirements, PAAB Code standards, and the Canadian preclearance process. • Ability to evaluate clinical evidence, product labeling, safety information, comparative claims, real-world evidence, and market access messaging for promotional compliance. • Knowledge of fair balance principles, risk communication requirements, claim substantiation, and evidence-based promotional practices. • Strong project management, prioritization, and decision-making capabilities. • Excellent written and verbal communication skills with the ability to provide practical, solution-oriented regulatory guidance to senior stakeholders. • Experience supporting both US and Canadian promotional review activities for prescription drugs, biologics, or biosimilars preferred. • Direct experience with OPDP advisory submissions, FDA promotional correspondence, PAAB submissions, and Canadian preclearance review processes preferred. • Experience supporting product launches, new indications, label updates, digital campaigns, congress materials, omnichannel initiatives, and competitive response strategies preferred. • Familiarity with electronic promotional review systems, document management platforms, reference management tools, and audit-ready documentation practices preferred. • Experience mentoring or providing guidance to junior regulatory professionals preferred.

🏖️ Benefits

• generous flexible paid time off program • company-paid holidays • flexible working hours • remote work options