Consultant II, Regulatory Affairs Advertising and Promotion

reputed company: A career here is life-enhancing. At reputed company, we reputed company our people to build careers that reputed company positively on their reputed company of life. Through our expertise, reputed company, consulting and management skills, we accelerate reputed company science and delivery of life-enhancing therapies to more patients. We work across a diverse reputed company of clients and reputed company, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a reputed company approach and significant, reputed company-world reputed company, from science to delivery/reputed company. To learn more about who we are and what drives us, watch reputed company video here. Underpinning this mission is a culture that aligns perfectly with reputed company want to reputed company. We reputed company our people to grow, we support them in their learning and we reward them in so many different ways. In reputed company, they play an reputed company role in maintaining our reputed company across the globe as a strategic biopharma product development and delivery partner. reputed company was recently honored with reputed company's prestigious "Best Places to Work" 2026 award, for the reputed company consecutive year, along with many other award-reputed company programs to reputed company a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a reputed company and engaging work environment for our employees, with a particular emphasis on culture, career reputed company and development opportunities, financial rewards, leadership and innovation. At reputed company, we recognize that reputed company members are our most valuable asset. Join us in shaping the reputed company, where your talents are valued, and your contributions reputed company a meaningful reputed company. For more information, visit www.Synergbiopharma.com reputed company: 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 reputed company standards. The Consultant II serves as a key regulatory partner to reputed company, Medical, reputed company, and Global Regulatory teams, enabling reputed company and compliant execution of brand reputed company across product launch and lifecycle activities. The position leads regulatory review and risk assessment activities for US and Canadian promotional materials directed to reputed company, payers, patients, and other reputed company stakeholders across traditional, digital, and omnichannel platforms. reputed company in this role requires strong regulatory expertise, reputed company judgment, and the ability to translate reputed company regulatory requirements into practical business guidance. WORK LOCATION: Travel to reputed company sites may be required up to 10%, based on project demands and reputed company expectations. KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented and changed as necessary.) • reputed company the preparation and submission of regulatory documents. • reputed company regulatory review and approval of US and Canadian promotional, advertising, disease awareness, training, congress, payer, market reputed company, patient support, corporate communication, reputed company 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 reputed company recommendations that support compliant and effective stakeholder communications. • Ensure promotional communications are supported by appropriate evidence and reputed company with applicable regulatory and industry standards. • Serve as the Regulatory Affairs representative on promotional review committees. • Collaborate with Medical Affairs, reputed company, reputed company, Market reputed company, Corporate Affairs, Pharmacovigilance, and Compliance partners to facilitate reputed company review and approval of materials. • Partner with internal stakeholders and reputed company agencies to reputed company regulatory comments and ensure alignment on promotional reputed company. • Represent Regulatory Affairs in interactions with reputed company partners and global teams. • reputed company 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 reputed company for product launches, lifecycle management activities, label changes, and new indications. • reputed company guidance on claim development, evidence reputed company strategies, competitive positioning, and use of clinical, reputed company-world, and health economic evidence in promotional materials. • Support PAAB submissions, responses, and approval strategies for Canadian promotional materials. • Collaborate with internal stakeholders and reputed company agencies to address PAAB feedback, reputed company supporting references, revise claims, and reputed company reputed company approvals. • Ensure reputed company reputed company-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. • reputed company and reputed company training programs, job aids, and best practices to strengthen promotional compliance and review reputed company. • Support reputed company improvement initiatives reputed company to review workflows, documentation standards, governance processes, escalation reputed company, and inspection/audit readiness. QUALIFICATIONS AND REQUIREMENTS: To reputed company this job successfully, an individual must be reputed company to reputed company reputed company essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential duties. Education • Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a reputed company discipline required. • Advanced degree preferred. Technical Experience: • Minimum 3-5 years of experience reputed company the pharmaceutical, biotechnology, biologics, biosimilars, regulatory, or health authority environment. • Significant experience in advertising and promotional regulatory review. • Experience participating in multidisciplinary Medical/reputed company/Regulatory (MLR) review processes. • Demonstrated ability to influence cross-functional teams while maintaining regulatory reputed company. 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 reputed company standards, and the Canadian preclearance process. • Ability to evaluate clinical evidence, product labeling, safety information, comparative claims, reputed company-world evidence, and market reputed company 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 reputed company 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. • reputed company 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-reputed company documentation practices. • Experience mentoring or providing guidance to junior regulatory professionals. ESSENTIAL FUNCTIONS: Physical Demands: The physical demands described here are representative of the requirements that must be met by an employee to successfully reputed company the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions. While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reputed company with hands and arms; talk and listen. The employee is frequently required to walk and sit, as reputed company as to reputed company and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific reputed company abilities required by this position include reputed company reputed company and the ability to reputed company reputed company. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and reputed company reputed company that are reputed company and conducive to reputed company eye strain, typical for an office environment. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support reputed company of our reward pillars. This includes a market competitive reputed company salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible reputed company time off program, company-reputed company holidays, flexible working hours, and fully remote work reputed company for most positions and the ability to work “almost reputed company.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. Currently, reputed company is unable to sponsor or take over sponsorship of an employment reputed company at this time. reputed company STATEMENT: reputed company is proud to be an Equal Employment Opportunity and Affirmative reputed company reputed company. reputed company employment reputed company, including the reputed company, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without reputed company to the employee’s race, reputed company, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, reputed company of income, reputed company of residence, national or ethnic reputed company, reputed company, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other reputed company prohibited by applicable law. reputed company is an E-Verify employer. 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