The U.S. Pharmacopeial Convention (USP) Senior Regulatory Affairs Engagement Manager in Rockville, Maryland
Summary of the Position
The Senior Regulatory Affairs Engagement Manager will lead the implementation of a strategy to strengthen and expand the collaborative relationship between USP and U.S. regulatory agencies to advance quality in medicines, particularly in the areas of small molecules and excipients. This individual contributor role provides an opportunity to serve as a key function within USP for leading interactions and engagement with the U.S. Food and Drug Administration (FDA) and other regulatory authorities on priority areas. The successful candidate will be joining a dynamic team that is focused on stakeholder engagement, evidence development, communications, and public policy and will work closely with and foster collaboration among team members and across divisions.
Roles and Responsibilities
Lead regulatory engagement activities and interactions in areas of USP priority (primarily in the areas of small molecules and excipients) and provide guidance on the interaction between FDA regulatory science practices and USP compendial science development.
Develop opportunities for collaboration with US regulatory agencies. Prioritize issues of critical importance to FDA and other regulatory agencies with respect to USP strategies and goals, identify the core issues and their impact, and act as a conduit for review and escalation of potential collaborations and partnerships.
Working across USP, identify, monitor, and analyze compendial science initiatives, organizational developments, and trends that may impact FDA and other regulatory engagement strategies.
Support implementation of a consistent approach to managing engagements with FDA staff.
Bachelor’s degree (BS/BSc or BA), in a scientific, policy, or health-related discipline
Eight (8) years of experience in the medical technology, pharmaceutical, or life sciences industries with prior experience working within or interacting with the FDA.
Experience with supporting a strategic initiative or business function. Experience includes implementing strategy for a key function; supporting organization-wide initiative(s) or a functional group/team; and providing strategic direction to managers and directors on key organizational priorities.
Knowledge of FDA organization, functions, and processes.
Demonstrated ability to build sustainable relationships with U.S. regulators.
Broad experience (e.g., manufacturing, compendial, and regulatory requirements) for small molecules and excipients.
Demonstrated initiative and ability to successfully manage multiple priorities and projects in a fast-paced environment.
Well-developed and strong organizational, interpersonal communications, presentation, facilitation, writing, and listening skills with the ability to respond to fast changing workload.
Advanced degree in chemistry, biology, medicine, allied health science, or other related field preferred.
Strong knowledge of USP organization, functions, and processes as well as knowledge of FDA compendial processes.
Knowledge of the life sciences industry especially in areas of regulatory affairs, manufacturing, and quality.
Comfortable dealing with complex science, legal, and policy related issues, with a demonstrated ability to simplify and communicate complex science, legal and regulatory policy issues effectively.
Solution-oriented and innovative; can identify creative options for resolving issues that respond to multiple stakeholder interests and needs.
Demonstrated success in working in a matrixed organization, coordinating across functional areas; ability to influence and drive initiatives and lead without direct authority.
Strong critical thinking and problem-solving skills.
Demonstrable commitment to public health/patient safety/consumer protection, familiarity with global public health issues is an advantage.
USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing are protected.
COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired:
As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully present vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Ext. Affairs, Regulatory, & Communications
Job Type Full-Time