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Consultant II

2 months, 1 week ago
Anywhere, United States, Canada
Full-time
Mid Level
Consultant
Operations
Apply Now
Syner-G BioPharma

Syner-G BioPharma

Syner G BioPharma Group offers leading CMC & Regulatory Affairs solutions for biopharma, specializing in strategic CMC 360 services, global regulatory affairs, and quality compliance to support successful drug development.

Professional Services
51-250
Founded 2007
View All Jobs 8

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 alignment with approved labeling, scientific evidence, fair balance, risk communication, comparative claims, audience targeting, and regulatory compliance.
  • Conduct risk assessments and provide recommendations that support compliant stakeholder communications.
  • Serve as the Regulatory Affairs representative on promotional review committees and partner with cross-functional teams to resolve comments.
  • Provide strategic guidance on FDA, OPDP, Health Canada, and PAAB requirements for promotional materials and submission readiness.
  • Support product launches, lifecycle management, label changes, and new indications with compliant promotional strategy.
  • Guide claim development, evidence generation, competitive positioning, and use of clinical, real-world, and health economic evidence.
  • Support PAAB submissions, responses, and approval strategies for Canadian promotional materials.
  • Monitor regulatory and industry developments and communicate changes and business implications to stakeholders.
  • Develop training, job aids, best practices, and continuous improvement initiatives for promotional compliance and review processes.

Requirements

  • Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline required.
  • Advanced degree preferred.
  • 3-5 years of experience in 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.
  • 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.
  • Strong project management, prioritization, and decision-making capabilities.
  • Excellent written and verbal communication skills for providing practical 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 guiding junior regulatory professionals (preferred).
  • Ability to travel to client sites up to 100% based on project demands and client expectations.

Benefits

  • Market-competitive base salary and annual incentive plan.
  • Robust benefits offerings.
  • Generous flexible paid time off program.
  • Company-paid holidays.
  • Flexible working hours.
  • Fully remote work options for most positions.
  • Ability to work almost anywhere.
  • Career development and ongoing recognition opportunities.

Interested in this position?

Apply directly on the company website

Apply Now

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