Director, US Regulatory Policy & Intelligence

Company: National Black MBA Association
Location: Gaithersburg
Posted on: November 20, 2024

Job Description:

This is what you will do:The Director, US Regulatory Policy & Intelligence (RPI), is responsible for US regulatory policy activities within the Regulatory Science & Execution team. This includes identifying and advocating for US regulatory policies specific to Alexion business goals, developing policy positions, and conveying Alexion positions to relevant stakeholders. This will be done in close collaboration with Alexion and AstraZeneca colleagues through participation on external and internal work groups, analysis of the impact of proposed US policy changes, communicating to relevant internal stakeholders, and providing insights that advance regulatory strategies. The aim of this position is to partner with cross-functional colleagues, US and global regulatory leads, the Regulatory Intelligence & Policy team, and US Corporate Affairs, as well as engaging regulatory authorities, industry, patient advocates, professional associations, and other stakeholders to progress development activities of the pipeline. This position is an integral part of the Global Regulatory Affairs - Regulatory Science & Execution (GRA-RSE) team.Based on the above activities, it is expected that he/she will be a key partner across R&D and other areas of the organization to ensure that Alexion's regulatory strategies and activities are based on an adequate understanding of the US regulatory environment.The Director, Regulatory Policy & Intelligence (RPI) will:

• Represent Alexion and our business interests in trade association working groups.
• Work collaboratively with cross-functional partners within Alexion to identify regulatory policy priorities and develop positions.
• Work collaboratively with partners within AstraZeneca Regulatory Policy to ensure alignment on regulatory policy priorities and develop positions to inform regulatory strategy.
• Work with US Corporate Affairs team to assist in the development of response and stakeholder engagement strategies to address unexpected regulatory challenges.
• Collaborate with US Corporate Affairs team to ensure that regulatory intelligence is effectively integrated into the broader policy and advocacy strategies.
• Work collaboratively with other experts in a pre-competitive manner to build a Regulatory Policy network to support Alexion and AstraZeneca priorities.
• Communicate clearly and effectively (verbally and written) on US Regulatory Policy developments to a broad, diverse, and global audience.
• Actively contribute to the development of an Alexion RPI group dedicated to providing information that advances regulatory strategies for Alexion's products and R&D activities.
• Identify areas where continuous, new, or increased external engagement will progress our business goals.
• Actively engage with senior leaders to discuss strategic topics that require understanding of the US regulatory environment.You will need to have:
• A degree in life sciences or health-related discipline.
• Minimum of 7 years of life sciences and regulatory experience.
• Experience working in R&D organizations and cross-functional teams.
• Good knowledge and interest in the regulatory system of major jurisdictions (EU and US).
• Excellent communication skills, both verbally and written (proficiency in English required).
• Motivated to develop as a regulatory and R&D professional and to partner effectively with other colleagues to achieve business goals.
• The duties of this role are generally conducted in an office environment. Employees should be able to (with or without accommodation) use a computer; engage in communications via phone, video, and electronic messaging; problem-solve; engage in complex and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:
• Solution-seeking attitude and able to adapt to change.
• Passionate to promote a culture of teamwork, joy at work, and putting patients at the center of our daily work.
• Previous experience in regulatory policy and intelligence activities, including in writing summaries/reports for different audiences.
• Previous experience in a regulatory authority and/or pharmaceutical industry.
• Supplementary education in life sciences with a regulatory component or previous regulatory training.
• Proficient management of regular IT tools (MS Office, notably PowerPoint and Excel, amongst others).The annual base pay for this position ranges from $165,300.80 - $247,951.20. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.Date Posted14-Nov-2024Closing Date28-Nov-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify. AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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Keywords: National Black MBA Association, North Bethesda , Director, US Regulatory Policy & Intelligence, Executive , Gaithersburg, Maryland