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Syner-G

Consultant II, Regulatory Affairs Advertising and Promotion

RemoteUnited States only
Published
Experience
Mid
Employment
Full-time
Salary not disclosed
Check eligibility

Open to US only. Set where you work from to check your eligibility.

No BS summary

Regulatory affairs advertising and promotion consultant with 3-5 years in pharma/biotech/regulatory or health authority environments. Must know FDA/OPDP, Health Canada, PAAB, MLR review, and promotional compliance for US and Canadian materials. Remote role, no visa sponsorship.

Optional skills

Electronic promotional review systemsDocument management platformsReference management tools

What you'll do

  • Oversee the preparation and submission of regulatory documents.
  • 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 for assigned products.
  • Evaluate materials for consistency with approved labeling, scientific evidence, fair balance requirements, risk communication, comparative claims, appropriate audience targeting, and overall regulatory compliance.
  • Conduct risk assessments and provide recommendations that support compliant and effective stakeholder communications.
  • Ensure promotional communications are supported by appropriate evidence and aligned with applicable regulatory and industry standards.
  • Serve as the Regulatory Affairs representative on promotional review committees.
  • Collaborate with Medical Affairs, Legal, Commercial, Market Access, Corporate Affairs, Pharmacovigilance, and Compliance partners to facilitate timely review and approval of materials.
  • Partner with internal stakeholders and external agencies to resolve regulatory comments and ensure alignment on promotional strategy.
  • Represent Regulatory Affairs in interactions with alliance partners and global teams.
  • Provide strategic guidance regarding FDA and OPDP requirements for prescription drug advertising, promotional labeling, product claims, risk communication, and submission readiness.
  • Advise teams on Health Canada advertising requirements, PAAB standards, and Canadian promotional review expectations.
  • Support promotional strategy for product launches, lifecycle management activities, label changes, and new indications.
  • Provide guidance on claim development, evidence generation strategies, competitive positioning, and use of clinical, real-world, and health economic evidence in promotional materials.
  • Support PAAB submissions, responses, and approval strategies for Canadian promotional materials.
  • Collaborate with internal stakeholders and external agencies to address PAAB feedback, develop supporting references, revise claims, and achieve timely approvals.
  • Ensure healthcare professional-directed materials meet PAAB preclearance requirements and industry standards.
  • Monitor FDA, OPDP, Health Canada, PAAB, and industry developments, including enforcement trends, guidance updates, and evolving regulatory expectations.
  • Communicate regulatory changes and business implications to key stakeholders.
  • Develop and deliver training programs, job aids, and best practices to strengthen promotional compliance and review quality.
  • Support continuous improvement initiatives related to review workflows, documentation standards, governance processes, escalation pathways, and inspection/audit readiness.

What they require

  • 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.
  • Preferred: 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 audit-ready documentation practices.
  • Preferred: Experience mentoring or providing guidance to junior regulatory professionals.
  • Travel to client sites may be required up to 10%, based on project demands and client expectations.
  • Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.

Benefits

  • Market competitive base salary and annual incentive plan.
  • Robust benefit offerings.
  • 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 and the ability to work “almost anywhere.”
  • Office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Syner-G

Syner-G is a strategic biopharma product development and delivery partner supporting clients from drug discovery and approval through commercialization.

Biopharma

Details

Visa sponsorshipNo
Apply routeGreenhouse
Salary not disclosed