Description:The Senior Regulatory Affairs Manager, Advertising and Promotion is responsible for the review of Advertising and Promotional (Ad Prom) material for the Pharmaceutical Segment and accountable for all operational aspects of regulatory submissions providing planning and technical support for client’s products both on market and new product launches.What You'll be DoingReview of Marketing materials to ensure compliance with current regulations and guidance's.Contribute to the development of marketing strategies including providing regulatory guidance and solutions to help reach business objectives.Plan and manage complex projects and prioritize workload.Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with client and external standards.Maintain appropriate communication within the RA function, Marketing, and other functions primarily at the project team level.Communicate proactively and report to regulatory authorities.Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks.Contribute to the development and maintenance of processes and system for the review, approval, and submission of promotional materials.Set team, group, or service objectives to assure they align with the Regulatory strategy.Provide technical and strategic input for regulatory decisionsMay manage budget at country level.May provide direct supervision of individuals including mentoring, performance management and staffing decisions.What You'll BringMinimum of 7 years of experience in Regulatory Affairs Advertising & Promotion, including managing people or projects. Higher degree/PhD will be an advantage.Expert Regulatory knowledge in the Ad Prom space and other Regulatory functions.Strong ability to work with cross-functional teamsAbility to oversee multiple projects in a matrix team environment.Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities.Excellent oral and written communication and presentation skills.Ability to accomplish results through others.Ability to lead, coach, and motivate others.Bachelor’s degree or country equivalent in related scientific discipline.Bachelor’s degree RequiredHow many years of recent experience does this person need to have? +5 yearsTop 3-5 Must Have Non-negotiable Skills RequiredAt least 5 years of direct RA Ad Prom review experience for drug productsExperience with Promomats/Veeva SystemExperience with 2253 submissionsStrong collaboration and ability to work with cross-functional teamsNice to Have SkillsMedical or Scientific backgroundNotes:Work Schedule: 40hrs/weekVIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status
Description:The Senior Regulatory Affairs Manager, Advertising and Promotion is responsible for the review of Advertising and Promotional (Ad Prom) material for the Pharmaceutical Segment and accountable for all operational aspects of regulatory submissions providing planning and technical support for client’s products both on market and new product launches.What You'll be DoingReview of Marketing materials to ensure compliance with current regulations and guidance's.Contribute to the development of marketing strategies including providing regulatory guidance and solutions to help reach business objectives.Plan and manage complex projects and prioritize workload.Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with client and external standards.Maintain appropriate communication within the RA function, Marketing, and other functions primarily at the project team level.Communicate proactively and report to regulatory authorities.Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks.Contribute to the development and maintenance of processes and system for the review, approval, and submission of promotional materials.Set team, group, or service objectives to assure they align with the Regulatory strategy.Provide technical and strategic input for regulatory decisionsMay manage budget at country level.May provide direct supervision of individuals including mentoring, performance management and staffing decisions.What You'll BringMinimum of 7 years of experience in Regulatory Affairs Advertising & Promotion, including managing people or projects. Higher degree/PhD will be an advantage.Expert Regulatory knowledge in the Ad Prom space and other Regulatory functions.Strong ability to work with cross-functional teamsAbility to oversee multiple projects in a matrix team environment.Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities.Excellent oral and written communication and presentation skills.Ability to accomplish results through others.Ability to lead, coach, and motivate others.Bachelor’s degree or country equivalent in related scientific discipline.Bachelor’s degree RequiredHow many years of recent experience does this person need to have? +5 yearsTop 3-5 Must Have Non-negotiable Skills RequiredAt least 5 years of direct RA Ad Prom review experience for drug productsExperience with Promomats/Veeva SystemExperience with 2253 submissionsStrong collaboration and ability to work with cross-functional teamsNice to Have SkillsMedical or Scientific backgroundNotes:Work Schedule: 40hrs/week
(Please ensure email matches your resume email)
(document types allowed: doc/docx/rtf/pdf/txt) (max 2MB)
By submitting this form, you are consenting to the VIVA team contacting you via Phone/Email