Associate Dir, Global Regulatory Promo and Ads
We Aspire to Cure Cancer! Millennium is a leading biopharmaceutical company focused on oncology that combines the agility, ideals and camaraderie of a start-up with the resources of Japan's largest pharmaceutical company. The result is a creative, entrepreneurial environment where quality science and making a difference in patients' lives are the priorities. Here, employees who share a drive and commitment to innovation for the benefit of oncology patients find their ideas, experience and contributions are valued and rewarded. Millennium offers great benefits, a friendly and respectful atmosphere, and a culture that promotes flexibility between work and life and encourages employees to give back to their community.
* Provide regulatory strategic oversight for 2+ therapeutic areas or one highly complex therapeutic area with multiple products to ensure regulatory compliance of promotional materials generated for assigned compounds.
* Understands and interprets complex scientific issues as it relates to regulatory requirements and promotional strategy. Responsible for all regulatory aspects of multi-disciplinary or multi-faceted marketing programs
* Able to mentor and develop staff. Supervises trains and provides technical and regulatory guidance to staff.
* Represents the company at regulatory meetings.
* Interacts with all levels of staff at the FDA Office of Prescription Drug Promotion (OPDP). Acts as the lead regulatory representative at OPDP meetings. Provides strategic direction for OPDP meeting preparations. Negotiates regulatory issues with OPDP.
* Interacts with International Agencies regarding promotional issues as needed Dut
ies and Responsibilities:
* Collaborate with MRL Team and execute and approve major Global/US campaigns. Manage and inform moderate risk.
* Manage submissions including major launch campaigns. Plans, executes and manages regulatory OPDP submissions for assigned compounds. Delegation to staff as appropriate.
* Review and oversee responses to enforcement actions.
* Understands broad concepts within regulatory affairs and implications across organization. Proactively identifies regulatory issues. Offers creative solutions and strategies, including risk mitigation strategies
* Executes regulatory activities and provides regulatory support on projects in accordance with applicable regulations and guidelines. Ensures regulatory compliance of promotional materials generated for assigned compounds.
* Provides product development strategy and label development strategy as needed to ensure claims can be supported.
* Evaluates regulatory risks and makes recommendations relative to the overall MRL strategy.
* Manages others regulatory professionals as assigned. Able to mentor and develop staff. Identifies and proposes solutions to management for any resource gaps for brand responsibilities.
* Sets direction for the review of competitive materials, globally as needed, and interactions with FDA to urge enforcement activity as necessary.
* Presents to Senior Mgt. and cross-functional teams.
* Lead for Regulatory Promotion and Advertising Review for licensing opportunities.
* Other duties as assigned Qualifications:
* BS/BSc, preferred; BA accepted, PharmD preferred
* > 8 years industry; inclusive of > 6 years regulatory or related experience. Less experience may be acceptable with PharmD degree.
* Previous experience in Regulatory Affairs promotion and advertising; experience in managing major regulatory filing(s) e.g. Launch Advisory Materials or responses to enforcement letters.
* Prior people management experience not required, but preferred
* Extensive knowledge of applicable FDA regulations.
* Able to provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials.
* Able to deal with issues of critical importance, provides regulatory advice and decision involving regulatory issues on topics for which there may not be clear/specific regulatory guidance
* Understands regulatory, quality and safety systems impacting drug development and marketed product support.
* Functions independently as a decision-maker on regulatory issues.
* Excellent oral and written skills, timeline responsibilities, negotiations skills. Works well with others, especially on a cross-functional team, direct reports and senior leadership.
* Understands the phases, processes and techniques used within a clinical development environment, can contribute to clinical study design discussions as needed.
* Understand FDA regulations relative to advertising and promotion, for health professional and consumer audiences. Experience in managing multiple filings e.g. Launch Advisory Materials or responses to enforcement or proactive complaints to OPDP about competitors.
* Understands the pharmaceutical industry and has experience in evaluating promotion and advertising materials in multiple therapeutic areas.
* Maintains a current knowledge of applicable government regulations, particularly those related to advertising and promotion including major global codes of practice and regulations. Has a thorough knowledge of historical enforcement actions and is readily able to use this in negotiation.
* Demonstrated leadership skills. Ability to effectively manage and bring working teams together for common objectives Models leaders at all levels daily.
* Regulatory Affairs Certification (RAC) desirable.
* Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required. * Requires approximately 20 % travel. Takeda provides equal employment [and affirmative action] opportunities to minorities, females, veterans, and disabled individuals, as well as other protected groups.
Application URL: http://www.aplitrak.com/?adid=bWljaGFlbC5tY2ZhcmxhbmUuMzk4NjMuMzE2N0BtcGkuYXBsaXRyYWsuY29t