RemoteLeaf Logo
Log in Sign up

Consultant II

1 week, 1 day 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 6

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

Similar Roles

Caylent

Senior Change Strategist

Caylent 251-1K IT Services

Caylent is hiring a Senior Change Strategist to partner with clients on strategic transformations, technology implementations, and AI-driven adoption programs.

Canada Full-time Senior Consultant
$175k-$195k
AWS Generative AI
5 hours, 13 minutes ago
ELEVI Associates

Sr Consultant

ELEVI Associates 11-50 Internet Software & Services

ELEVI is hiring a Linux automation and infrastructure engineer to support warehouse imaging, server operations, monitoring, and performance testing for a federal/commercial environment.

Anywhere Full-time Senior Consultant
$12k-$145k
Ansible Bash CI/CD Go Grafana Linux Prometheus Python
5 hours, 42 minutes ago
PlayStation

Sr Director, Business Strategy and Planning

PlayStation 100K+ Household Durables

Sony Interactive Entertainment is hiring a Senior Director of Business Strategy & Planning to lead the Studio Business Group’s operating system, executive planning cadence, and strategic decision support.

United States Full-time Lead Consultant Executive Assistant
$252k-$378k
5 hours, 58 minutes ago
Caylent

Senior Change Strategist

Caylent 251-1K IT Services

Caylent is hiring a Senior Change Strategist to advise clients on adoption and organizational transformation for technology- and AI-driven initiatives in a fully remote global consulting environment.

United States Full-time Senior Consultant
$165k-$180k
AWS Generative AI
6 hours, 13 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers