Consultant II

🕒 August 5

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

💼 Consultant

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• Lead regulatory review and approval of US and Canadian promotional, advertising, disease awareness, training, congress, payer, market access, patient support, corporate communication, and digital materials. • Evaluate materials for approved-label consistency, scientific evidence, fair balance, risk communication, comparative claims, audience targeting, and regulatory compliance. • Conduct risk assessments and provide recommendations for compliant stakeholder communications. • Serve as the Regulatory Affairs representative on promotional review committees. • Collaborate with Medical Affairs, Legal, Commercial, Market Access, Corporate Affairs, Pharmacovigilance, and Compliance partners. • Resolve regulatory comments with internal stakeholders and external agencies. • Represent Regulatory Affairs in interactions with alliance partners and global teams. • Provide strategic guidance on FDA and OPDP requirements, prescription drug advertising, promotional labeling, product claims, risk communication, and submission readiness. • Advise on Health Canada advertising requirements, PAAB standards, and Canadian promotional review expectations. • Support promotional strategy for product launches, lifecycle management, label changes, and new indications. • Guide claim development, evidence-generation strategies, competitive positioning, and use of clinical, real-world, and health-economic evidence. • Support PAAB submissions, responses, and approval strategies. • Monitor FDA, OPDP, Health Canada, PAAB, and industry developments. • Communicate regulatory changes and business implications to stakeholders. • Develop and deliver training programs, job aids, and best practices. • Support continuous improvement in review workflows, documentation, governance, escalation pathways, and inspection/audit readiness.

🎯 Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline required. • 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 review processes. • Demonstrated ability to influence cross-functional teams while maintaining regulatory integrity. • Strong knowledge of FDA promotional requirements and OPDP expectations. • 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. • Knowledge of fair balance principles, risk communication, claim substantiation, and evidence-based promotional practices. • Strong project management, prioritization, and decision-making capabilities. • Excellent written and verbal communication skills. • Advanced degree preferred. • Preferred: experience with US and Canadian promotional reviews, OPDP advisory submissions, FDA promotional correspondence, PAAB submissions, product launches, label updates, digital campaigns, omnichannel initiatives, electronic promotional review systems, document management platforms, reference management tools, audit-ready documentation, and mentoring junior professionals. • Ability to travel to client sites up to 100% based on project demands and client expectations. • Syner-G is unable to sponsor or take over sponsorship of an employment visa.

🏖️ Benefits

• Market competitive base salary • Annual incentive plan • Robust benefit offerings • Remote work/flexibility • Ongoing recognition and career development opportunities • Generous flexible paid time off program • Company-paid holidays • Flexible working hours • Fully remote work options for most positions • Ability to work “almost anywhere”