Milestone Technologies, Inc.
Director, Regulatory Affairs, Advertising & Promotion
Milestone Technologies, Inc., New York, New York, United States,
Position SummaryThe Director, Regulatory Affairs Advertising & Promotion will provide leadership, insight, and clear direction on all advertising, promotional programs, and tactics that are compliant with regulations, aligned with approved product registrations and company policies throughout the product life cycle. The Director will partner with all Regulatory Affairs functions, Medical Affairs, Legal, Compliance, Commercial/International distributors, and will serve as a key member of the Medical/Legal/Regulatory (MLR) Review Committee. This role will report to the Head of Commercial Regulatory Affairs & Labeling (Executive Director).
Job Functions/ResponsibilitiesProvide regulatory advertising/promotion leadership for assigned programs of marketed and investigational products in US and international regions.Conduct review and approval of advertising/promotional materials as the lead regulatory reviewer on the MLR Committee for US and international markets.Serve as the primary regulatory liaison to FDA/CDER/OPDP.Author regulatory submissions (Form 2253) and work closely with the publishing vendor to ensure timely submission of promotional materials to the Office of Prescription Drug Promotion (OPDP).Represent Regulatory Advertising/Promotion at labeling meetings and provide informed strategic regulatory guidance, as appropriate.Provide regulatory guidance on new promotional or disease awareness concepts and new campaigns that may be related to company products.Maintain a continued awareness and understanding of FDA and international (e.g., EU and ROW) Health Authority regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products. Monitor enforcement trends and provide timely advice to the team.Serve as an expert resource for regulatory advertising/promotion advice across departments.Contribute to process improvements relevant to commercial regulatory activities, including the MLR Committee.Develop and implement regulatory advertising/promotional processes, as necessary.Support product labeling activities as needed.
Experience :10+ years of biopharmaceutical industry experience, with 8+ years of experience in the regulatory review of advertising/promotional materials for prescription drug and/or biologic products.Experience representing Regulatory Affairs Advertising/Promotion on cross functional teams.Excellent planning and organizational skills and the ability to work on multiple projects with tight timelines.Excellent communication skills both verbal and in writing.
Education :Bachelor’s degree in a biological, life sciences, or related scientific discipline (pharmacy, medicine, etc.); an advanced degree is desirable.
Knowledge, Skills And AbilitiesDirect experience with FDA’s Office of Prescription Drug Promotion (OPDP) submissions and strategies. Experience with international (e.g., EU and ROW) Health Authorities is desirable; demonstrated contact through a CRO is acceptable.Extensive in-depth knowledge of regulatory requirements associated with advertising and promotion of prescription drug products, and experience in applying such requirements is required.Experience with using Veeva Vault RIM and QualityDocs is desirable.Experience with global rules and regulations regarding promotion of medical products is highly desirable.Excellent verbal, written, negotiation, influence and interpersonal communication skills required.Capable of critically reviewing complex technical/scientific documents and influencing colleagues across functions. Demonstrated ability to analyze and interpret efficacy and safety data is critical.Requires ability to work both independently and in a team environment, to set priorities to meet timelines, to motivate and influence others. Must be self-directed and proactive.Ability to engage multiple stakeholders to achieve business objectives, while building excellent working relationships.Strong team player that has a customer service approach and is solution oriented.
Job Functions/ResponsibilitiesProvide regulatory advertising/promotion leadership for assigned programs of marketed and investigational products in US and international regions.Conduct review and approval of advertising/promotional materials as the lead regulatory reviewer on the MLR Committee for US and international markets.Serve as the primary regulatory liaison to FDA/CDER/OPDP.Author regulatory submissions (Form 2253) and work closely with the publishing vendor to ensure timely submission of promotional materials to the Office of Prescription Drug Promotion (OPDP).Represent Regulatory Advertising/Promotion at labeling meetings and provide informed strategic regulatory guidance, as appropriate.Provide regulatory guidance on new promotional or disease awareness concepts and new campaigns that may be related to company products.Maintain a continued awareness and understanding of FDA and international (e.g., EU and ROW) Health Authority regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products. Monitor enforcement trends and provide timely advice to the team.Serve as an expert resource for regulatory advertising/promotion advice across departments.Contribute to process improvements relevant to commercial regulatory activities, including the MLR Committee.Develop and implement regulatory advertising/promotional processes, as necessary.Support product labeling activities as needed.
Experience :10+ years of biopharmaceutical industry experience, with 8+ years of experience in the regulatory review of advertising/promotional materials for prescription drug and/or biologic products.Experience representing Regulatory Affairs Advertising/Promotion on cross functional teams.Excellent planning and organizational skills and the ability to work on multiple projects with tight timelines.Excellent communication skills both verbal and in writing.
Education :Bachelor’s degree in a biological, life sciences, or related scientific discipline (pharmacy, medicine, etc.); an advanced degree is desirable.
Knowledge, Skills And AbilitiesDirect experience with FDA’s Office of Prescription Drug Promotion (OPDP) submissions and strategies. Experience with international (e.g., EU and ROW) Health Authorities is desirable; demonstrated contact through a CRO is acceptable.Extensive in-depth knowledge of regulatory requirements associated with advertising and promotion of prescription drug products, and experience in applying such requirements is required.Experience with using Veeva Vault RIM and QualityDocs is desirable.Experience with global rules and regulations regarding promotion of medical products is highly desirable.Excellent verbal, written, negotiation, influence and interpersonal communication skills required.Capable of critically reviewing complex technical/scientific documents and influencing colleagues across functions. Demonstrated ability to analyze and interpret efficacy and safety data is critical.Requires ability to work both independently and in a team environment, to set priorities to meet timelines, to motivate and influence others. Must be self-directed and proactive.Ability to engage multiple stakeholders to achieve business objectives, while building excellent working relationships.Strong team player that has a customer service approach and is solution oriented.