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Years of Experience
Date Last Verified
ProfileAssociate Program Director, Regulatory The candidate will lead Program Review Committees (PRCs) with oversight from CORA senior staff members. Provide regulatory support to assigned products or business areas and projects. Guide other departmental projects and other deliverables, in consultation with CORA senior staff members. Complete standard work with increasing levels of autonomy. Can be relied upon for sound regulatory guidance. Effectively integrate regulatory risk/context and business knowledge. Keep current in the areas of regulatory, healthcare compliance and ethics. Proactively identify and address compliance issues. Guide cross-functional interactions, projects and teams. Monitor PRCs and provide oversight for various scenarios that require such oversight, e.g., Food and Drug Administration (FDA) communications, audits, POC presentations, compliance violations, etc. Provide regulatory support for assigned products, business areas and projects under the guidance and direction of CORA senior staff member. With the guidance and support of a CORA senior staff member, lead/chair PRC meetings and effectively collaborate with cross-functional internal groups and external advertising agencies. Stay abreast of developments in therapeutic and disease areas, including the competitive landscape and other relevant commercial and development trends and dynamics to ensure a fully current view of implications for Genentech products. Support development of therapeutic-area strategy, conducting and summarizing product-specific analysis as requested. Obtain and apply knowledge of Roche and regulatory guidelines, policies, procedures and best practices. Maintain current awareness of evolving Food and Drug Administration (FDA) opinions; including advisory letters, enforcement letters and policy issues. Communicate significant changes or other relevant matters to internal partners and stakeholders. Collaborate with commercial leadership to impact marketing strategies, implementation and promotion goals. Facilitate the timely development and approval of disease state and promotional materials by interpreting and applying regulations and guidelines from the FDA and Roche policies. Provide regulatory input on commercial concepts and draft materials. Support correspondence with the FDA and interpretation of FDA comments. Including follow-on correspondence, such as resubmissions. Agilely represent commercial regulatory for Core Data Sheet (CDS) and U.S. product label development. As appropriate, provide commercial regulatory affairs input into the cross-functional regulatory strategy for each product or portfolio assignment. Keep internal partners and stakeholders abreast on primary PRC/CORA activities and status. Consult direct manager on all matters related to FDA communications, audits, POC presentations and compliance violations. Appropriate, participate as an ad hoc member in the Regulatory Affairs Functional Team (RAFT) for relevant products.
Qualification and Experience
The candidate must have Bachelors Degree (life sciences, law, public policy, marketing, business, education, or related discipline preferred). Should preferably have Graduate-level Degree (JD, MBA, MS, PharmD or other PhD, or related discipline). Must have 5+ years’ work experience in regulatory, legal, compliance, policy, auditing, training, communications or related disciplines in the bio/pharma industry. Previous experience in regulatory and/or commercial regulatory disciplines is preferred. Demonstrate working knowledge of the bio/pharma industry (compliance, legal, clinical affairs, regulatory and product marketing) as well as working knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.) is needed.
Job ID: 3411949215