Richard Lem Email & Phone Number

Irvine, California, Us

Head of International Regulatory Affairs Advertising and Promotion at Allergan Aesthetics leading the international (OUS) and UK affiliate Regulatory Affairs Advertising and Promotion teams who collaborate with cross functional partners and provide strategic oversight into the commercial activities of the aesthetics portfolio

Irvine, California, Us

Head of International Regulatory Affairs Advertising and Promotion at Allergan Aesthetics leading a diverse team who collaborate with cross functional partners and provide oversight into the commercial activities of the aesthetics portfolio across ex-US regions

Irvine, California, Us

Implement guidelines and standards for global review of promotional materials to accelerate implementation of global to local tactical execution

New York, Ny, Us

Head of US Regulatory Affairs Advertising and Promotion responsible for building a right-sized team of talented individuals that collaborate with cross functional partners to find solutions to ensure promotional, medical, and scientific activities are compliant with US regulations, guidance, and internal policies and procedures• Establish internal processes across the Commercialization, Corporate Communications and R&D organizations to ensure compliant company communication and manage the internal review, approval, and submission processes for promotional, medical, and educational materials.• Collaborate with Clinical Regulatory and Development organizations to provide Regulatory guidance on global labeling and harmonize program timelines for launch preparations or label updates• Oversee collaborative working relationships with OPDP to support requests for advisory comments, post-marketing and accelerated approval compliance, and responses to Agency inquiries

Leverkusen, North Rhine-Westphalia, De

• Successful record as advertising and promotion regulatory lead on accelerated approval launches for oncology products• Develop internal best practices for the regulatory submission of accelerated approval products' promotional materials• Establish eCTD submissions for drug promotion and advertising to OPDP• Foster collaborative working relationships with new and existing OPDP review teams • Moderate cross department meetings and educate on past OPDP advisory comments, recent OPDP violation letters and guidance documents, and first amendment cases on pharmaceutical advertising• Lead Lean Operational Excellence project to streamline internal communication on critical Health Authority communications

Leverkusen, North Rhine-Westphalia, De

• Commercial regulatory lead for Oncology promotional review committees • Provide regulatory insight for the development of new or updated internal procedures, including promotional review processes• Mentor Bayer employees, post-doctoral fellows, and regulatory affairs interns through the Advertising and Promotion rotation

Cambridge, Ma, Us

• Commercial regulatory lead for the Hemophilia brand promotional review committees • Developed draft promotional materials for FDA advisory comment submission• Provide regulatory insight for the development of new or updated internal procedures• US regulatory lead for supplemental BLA label submission• Director of the Regulatory Affairs – ALP post-doctoral fellowship

Cambridge, Ma, Us

• Regulatory lead for two promotional review committees, including one product in its launch phase• Preceptor for the Regulatory Affairs – ALP post-doctoral fellowship

Cambridge, Ma, Us

Regulatory Affairs - Advertising, Labeling, and Promotion:• Regulatory reviewer for neurology franchise promotional review and assisted in the regulatory review and submission for two product launches.• Analyzed FDA approval packages to assist in the US label development for a biologic launch product.• Reviewed recent OPDP letters and distributed summaries to all cross-functional teams to maintain a current understanding of regulatory enforcements.• Preceptor for APPE pharmacy students in the Regulatory Affairs rotation • Researched current industry trends for FDAMA Section 114 policy implementation and development US Marketing:• Served as the marketing lead in the promotional review committee for a subpart H biologic product’s personal promotion pieces, non-personal promotional pieces, and associated sales training modules • Strategic US launch readiness team lead for the anticipated launch of a competitor biologic product

Quincy, Ma, Us

Boston, Ma, Us

• Served as the MFN representative on the Dean’s Advisory Committee• Ensured that all tasks delegated to project leads and to committee chairs are carried out in a timely manner• Organized agenda for bi-monthly Executive-Board meetings and quarterly general membership meetings• Presided over bi-monthly Executive-Board meetings• Led the discussion to outline the annual schedule for the Conference Series and recruit lead fellow from each partnering company to spearhead quarterly conference• Collaborated with MFN committee chairs to create Best Practice Guidelines

Boston, Ma, Us

• Precepted PharmD APPE students in the Industry: Regulatory Affairs-ALP rotation at Biogen Idec• Presented overview of Regulatory Affairs-ALP and Marketing overview during Industry Seminar