This role is responsible for ensuring 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. The Consultant II serves as a key regulatory partner to Commercial, Medical, Legal, and Global Regulatory teams, enabling timely and compliant execution of brand strategy across product launch and lifecycle activities.

The position leads regulatory review and risk assessment activities for US and Canadian promotional materials directed to healthcare professionals, payers, patients, and other external stakeholders across traditional, digital, and omnichannel platforms. Success in this role requires strong regulatory expertise, sound judgment, and the ability to translate complex regulatory requirements into practical business guidance.

WORK LOCATION:

Travel to client sites may be required up to 10%, based on project demands and client expectations.

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented and changed as necessary.)

• 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.

QUALIFICATIONS AND REQUIREMENTS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Education

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline required.
• Advanced degree preferred.

Technical Experience:

• 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.

Knowledge, Skills, and Abilities:

• 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 Qualifications

• Experience supporting both US and Canadian promotional review activities for prescription drugs, biologics, or biosimilars.
• Direct experience with OPDP advisory submissions, FDA promotional correspondence, PAAB submissions, and Canadian preclearance review processes.
• Experience supporting product launches, new indications, label updates, digital campaigns, congress materials, omnichannel initiatives, and competitive response strategies.
• Familiarity with electronic promotional review systems, document management platforms, reference management tools, and audit-ready documentation practices.
• Experience mentoring or providing guidance to junior regulatory professionals.