Associate Group Director, Regulatory Intelligence & Policy

Transcription

1 Date: 06/24/16 Associate Group Director, Regulatory Intelligence & Policy Job ID: Job Function Project Management Regulatory Affairs Location United States - District of Columbia Washington Company/Division Full-time Schedule Full-time Job type Regular Employee Job Level Manager with Direct Reports Who We Are At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading researchfocused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to dtevelop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work. The Position This position is located in our Washington DC Office GENERAL POSITION SUMMARY/PURPOSE:Regulatory Intelligence & Policy is part of the broader PDR organization that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for Roche s global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. Directors and Senior Directors in Regulatory Intelligence & Policy are assigned responsibilities by varying projects, as business needs dictate, and often perform work that transcends multiple or all therapeutic areas. Regulatory Intelligence & Policy is responsible for the development and implementation of regulatory policy strategies based on regulatory and legislative trends important to Roche s product portfolio. Directors and Senior Directors make critical contributions to the annual and long-term vision, mission, strategy and infrastructure of Global PD Regulatory Intelligence & Policy. Directors and Senior Directors work closely with a host of subject matter experts to plan regulatory advocacy positions, strategies and tactics and facilitate engagement with regulators on key topics of interest. Regulatory Intelligence & Policy serves as a liaison with trade associations, think tanks, advocacy organizations and regulatory authorities; managing the strategy for and execution of these interactions. Regulatory Intelligence & Policy is also responsible for identifying,

2 documenting, coordinating and communicating regulatory intelligence activities and information. Senior Directors, by comparison to Directors, are considerably experienced in the director-level position and may be assigned the most complex business areas to support. JOB DESCRIPTION PRIMARY DUTIES AND RESPONSIBILITIES: Intact & Cross- Functional Teams Drive best practices and operational excellence within the department and crossfunctionally and ensures timely communication and information dissemination across the department and beyond Lead routine and ad hoc meetings with assigned Regulatory Intelligence & Policy staff Identify, lead special projects that further the success and effectiveness of Regulatory Intelligence & Policy and/or PDR overall As needed or otherwise appropriate, act as a substitute for his/her manager in various meetings, communications or other forums Consistently comply with all governing laws, regulations, Roche Standard Operating Procedures (SOPs), company HR policies & procedures. Regulatory Intelligence & Policy Responsible for the development and implementation of regulatory policy strategies based on regulatory and legislative trends important to the Genentech Roche product portfolio. Partner with subject matter experts to plan regulatory advocacy positions, strategies and tactics. Serve as a liaison with trade associations, think tanks, advocacy organizations and regulatory authorities and manages the strategy and execution of these interactions. Responsible for communicating and coordinating regulatory intelligence activities and work products. Support regulatory interactions on policy and advocacy issues, including building relationships with key regulatory decision makers. Analyze regulatory environment and advises US regulatory staff of potential impact. Strategize and presents action plans to mitigate future issues. Develop key positions as well as strategic and tactical plans to implement regulatory change / evolution. Partner with teams, Government Affairs, Trade Associations, Think Tanks, internal subject matter experts and Legal to implement plans. Write, coordinate and/or review commenting on regulatory or legislative initiatives and guidances Represent Genentech Roche at trade association meetings. Communicate specific regulatory trends, analysis and intelligence to global regulatory staff. Work with regulatory intelligence vendors to tailor implication messages for regulatory intelligence activities Stay abreast of internal and external developments, trends and other dynamics relevant to the work of PD and PDR to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for Roche therapeutic areas and product development projects. Drive internal and external awareness and ever-increasing knowledge and expertise across his/her staff regarding laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics Obtain and consistently apply in-depth knowledge of Roche and regulatory guidelines, procedures and best practices to their work Play lead role in annual and longer-term development of regional and/or global Regulatory Intelligence & Policy s vision, strategy, goals, objectives and infrastructure Maintain consistent oversight of deliverables and ensure issues are escalated when

3 Other needed and encourages resolution at the lowest appropriate level Drive effective and efficient support across and intelligence expertise to crossfunctional teams and other groups. Including providing leadership guidance regarding relevant regional regulatory policy and intelligence to regulatory leads Support regulatory interactions on policy and advocacy issues, including building relationships with key regulatory decision-makers Oversee and guide analysis of the regulatory environment and advice to PDR management and staff regarding potential implications. Includes communications regarding specific regulatory trends, analysis and intelligence to various internal functions. Support staff members and others, as needed, in strategizing and presenting opportunities to mitigate future issues Guide development and implementation of key positions, strategic and tactical plans Guide writing, coordination and reviews of comments on regulatory or legislative initiatives and guidance Represent Roche at trade associations and other external meetings or interactions Oversee and guide regulatory intelligence gathering, analysis, synthesis, summation and communication to internal functions and teams Routinely monitor site, regional and/or global departmental practices, processes, and procedures to ensure ongoing effectiveness, efficiencies, scalability and sustainability. As appropriate, identifies and recommends opportunities to streamline or otherwise improve Play a lead role in development and implementation of new or updated PDR and/or Regulatory Intelligence & Policy-specific systems, processes, SOPs, Department Operating Procedures (DOPs) or other relevant tools. Includes providing feedback on global SOPs and, where assigned, acting as a member of global committees or other taskforces Oversee and/or otherwise complete routine and ad hoc analysis and reporting. Accountable to ensure staff members keep all internal customers, partners and stakeholders abreast of progress and interim updates Proactively manags key partners and stakeholders across site, regional and global levels through effective, ongoing communications Who You Are QUALIFICATIONS & EXPERIENCE: Bachelors Degree required (law, public policy or life sciences disciplines strongly preferred) Advanced Degree in related field is preferred Average of 10 or more years work experience Significant regulatory affairs experience in drug/biologics development/manufacturing Extensive experience and proven expertise in regulatory policy and intelligence Extensive knowledge of international regulations, processes and issues in drug/biologics development. Includes expert-level knowledge of GxP (Good Practices for quality guidelines and practices in the pharmaceutical/biotechnology or related industry), GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines Previous experience working with senior-level members or officials of trade associations or other key groups that influence U.S. Federal public policies is a plus Existing relationships with U.S. Federal Government legislators, committees,

4 administrative staff, or other key parties or influencers In-depth familiarity with competitive activity in the field Experience participating in and/or otherwise supporting global product development or other cross-functional teams International (2 or more markets) regulatory experience is a plus Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) Fluent English and other language skills as needed ABILITIES: Has impeccable ethics. Demonstrates, or has proven abilities to demonstrate, Roche Values & Leadership Competencies Outstanding attention-to-detail Has consistently demonstrated outstanding leadership of multiple projects, initiatives and teams Consistently provides a motivating, elevating and inspiring environment in which to work Proven expertise in effectively and efficiently planning and resourcing multiple largescale and complex projects and initiatives on short-, medium- and long-term bases Regarded as a subject matter expert Outstanding business acumen: has superior knowledge of the pharmaceutical/biotechnology industry, the multiple functions and roles involved in the product development process. Makes significant contributions to the business Strategy agility: has broad experience in the pharmaceutical/biotechnology or related industry and is able to bring this to bear in accomplishing strategic goals and objectives Outstanding time management and organizational skills: proven abilities to manage multiple, often complex and sometimes competing, objectives, goals and priorities to effective and efficient conclusion Outstanding interpersonal skills: proven track record of building strong and sustainable relationships with internal and external partners and stakeholders Outstanding written communication skills Comfort around all levels of management; has demonstrated managerial courage in past positions and responsibilities Strong influencing skills: proven abilities to get things done without formal authority Strong negotiation skills: is highly adept at identifying solutions that will meet the needs of all involved parties Strong communication and presentation skills: exhibits professional maturity, confidence and competence. Knows how to summarize and communicate the key points and business case for others to effectively and expeditiously make important business decisions Outstanding judgment and decision-making skills: past results are indicative of consistently sound and effective business decisions Outstanding orientation to teamwork: works collaboratively, effectively and efficiently with others internally and externally Strong conflict resolution skills: proven abilities to effectively and expeditiously reach satisfactory resolution among all involved parties Strong financial acumen: proven abilities for planning, development and oversight of operating budgets and other resources Ability to travel *LI-PD-LK Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran

5 status. For more information about equal employment opportunity, visit our Genentech Careers page.