Program Director, Commercial Regulatory Affairs

Hoffmann-La Roche Ltd South San Francisco , CA 94080

Posted 2 weeks ago

Position ScopeProgram Director is the core individual contributor position for Commercial Regulatory Affairs (CORA) Review.Incumbents in this position: * Lead Program Review Committees (PRCs) independently * Demonstrate mastery of the review committee process and regulatory technical knowledge * Are the decision-makers for the PRCs in their designated therapeutic or business area assignments;independently leading cross-functional PRCs and modeling strong facilitation and decision-making skills * Represent Genentech in official FDA communications and sign-off on 2253s * Manage other departmental programs, projects and other deliverables with limited guidance from their managers * Require limited direction to complete standard and non-standard work * Can be relied upon for sound regulatory guidance and apply a strategic approach to problem-solving * Effectively integrate regulatory, legal and commercial context and business knowledge to address complexproblems * Keep current in the areas of regulatory, healthcare compliance and ethics * Proactively identify and address compliance issues * Regularly lead cross-functional interactions, projects and teams * Typically operate with a planning horizon of 6 - 12 monthsExample Duties and ResponsibilitiesPRC Leadership:o Lead/chair PRCs and effectively collaborate with cross-functional internal groups and external advertisingagencies; acting as the decision-maker for PRCs in the assigned therapeutic or business areao Monitor PRCs and provide management oversight for various scenarios that require such oversight, e.g.,Food and Drug Administration (FDA) communications, audits, POC presentations, compliance violations,etc.o Represent Genentech in official FDA communications and sign-off on 2253so Act as a primary Roche liaison to the FDA on relevant CORA activitieso Stay abreast of developments in therapeutic and disease areas, including the competitive landscape andother relevant commercial and development trends and dynamics to ensure a fully current view ofimplications for Genentech productso Support development of therapeutic-area strategy for CORA, conducting and summarizing product-specific analysis as requestedo Obtain and apply in-depth knowledge of Roche and regulatory guidelines, policies, procedures and bestpracticeso Maintain current awareness of evolving FDA opinions; including advisory letters, enforcement letters andpolicy issues. Communicate significant changes or other relevant matters to internal partners andstakeholderso Collaborate with commercial leadership to influence marketing strategies, implementation and promotionobjectiveso Facilitate the timely development and approval of disease state and promotional materials by interpretingand applying regulations and guidelines from the FDA and Roche policieso Provide regulatory input on commercial concepts and draft materialso Develop and implement effective strategies for FDA marketing, advertising and communicationssubmissionso Develop and deliver initial correspondence with the FDA and manage interpretation of FDA comments.Oversee and guide follow-on correspondence, such as resubmissionso Actively represent commercial regulatory for Core Data Sheet (CDS) and U.S. product label developmento Support development of the cross-functional regulatory strategy for each product or portfolio assignmentby providing commercial regulatory affairs expertise, insights, perspective and recommendationso Provide oversight and decision-making leadership to junior CORA staff as well as day-to-day guidance toother CORA team members supporting the same PRCs or other assignmentso Keep internal partners and stakeholders abreast on primary PRC/CORA activities and statuso Consult direct manager on all matters related to FDA communications, audits, POC presentations andcompliance violationsOther:o As appropriate, participate as an ad hoc member in the Regulatory Affairs Functional Team (RAFT) forrelevant productso As assigned, lead or otherwise participate in special projects and act as a standing or ad hoc member ofother teamsCompetencies successful candidates will demonstrate the following competencies critical to this position: * Strategic Agility- Articulates wise, long-term objectives and strategies. Links his/her responsibilities with themission of the whole organization. Regularly updates plans to reflect changing circumstances. Focuses onactivities that provide the most value. * Decision Making- Understands the broad context for decisions and reflects that context in how decisions aremade. Makes good decisions even in the face of ambiguous circumstances or contradictory requirements. Able tomanage divergent perspectives and to deliver difficult or unwelcome information in a constructive and productivemanner. Gathers information necessary to make decisions. Thinks through problems clearly and logically. Isdecisive; doesn't procrastinate on decisions. Expresses regulatory position and rationale clearly and fluently.Encourages direct and open discussions about important issues - eliminating churn and driving towards clarity. * Inspiring and Influencing- Fosters an exchange of ideas and support amongst colleagues. Is good at promotingan idea or vision: persuading. Works effectively with other people over whom he or she has no direct authority.Understands what motivates other people to perform at their best * Technical and Business Expertise- Has a firm grasp of internal and external conditions affecting theorganization. Applies emerging knowledge and trends in one's area of expertise to improve results. Builds strongrelationships with key customers. Contributes expertise to help colleagues within and beyond his or her area.Qualifications * Bachelors Degree (life sciences, law, public policy, marketing, business, education, or related discipline preferred)* Graduate-level Degree strongly preferred (JD, MBA, MS, PharmD or other PhD, or related discipline)Experience* 7 or more years' work experience in regulatory, legal, compliance, policy, auditing, training, communications or relateddisciplines in the bio/pharma industry * Regulatory advertising and promotion experience strongly preferred * Must demonstrate in-depth knowledge of the bio/pharma industry (compliance, legal, clinical affairs, regulatory andproduct marketing) as well as in-depth knowledge of the legal and regulatory environment, as it relates to healthcarecompliance in the bio/pharma industry (includes anti-kickback statutes, government fraud & abuse, off-labelpromotion, PhRMA Code, etc.)Additional Skills * Has impeccable ethics. Demonstrates, or has proven abilities to demonstrate, Roche Values, Competencies andLeadership Commitments (where applicable)* Strong influencing and negotiation skills: proven effectiveness leading diverse teams and influencing stakeholders ofvarying organizational levels without direct authority * Strong verbal and written business communication skills: highly adept at synthesizing and summarizing complexand/or voluminous content into clear, concise and actionable communications * Prepares well-researched and properly-toned emails in response to policy questions * Has demonstrated consistent abilities to complete assignments with limited direction (over a period of time)* Thinks "outside the box" for solutions. Applies creative problem-solving and appropriate business solutions toeffectively address compliance risk * Excellent project management skills; can prioritize multiple tasks and goals to ensure timely, on-target and within-budget accomplishment of such * Demonstrates ability to identify appropriate resources. Exercises good judgment in terms of when to leverage internalresources * Ability to travel (#LI-PDAB1Roche is an equal opportunity employer.Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs
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Program Director, Commercial Regulatory Affairs

Hoffmann-La Roche Ltd