(Senior) Regulatory Intelligence & Analysis Manager

Summary of the Position

The (Senior) Regulatory Intelligence & Analysis Manager will contribute in the development, implementation, and management of USP’s regulatory intelligence and analysis program.  This individual contributor role is accountable for monitoring and evaluating regulatory developments to inform enterprise decision making; to support regulatory interactions on policy issues; and to identify changes or opportunities that may impact USP’s standards, programs, and goals. The successful candidate will be joining a very 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

• Develops and executes a Regulatory Intelligence strategy. Keep abreast of internal and external changes, trends, developments and other dynamics relevant to the regulatory environment that may impact USP’s standards, programs, and goals. 

• Plays a key role in the development and implementation of systems and processes to monitor the regulatory environment for changes that may have an impact on USP's standards, programs, and goals. Develops and drives best practices and excellence in execution within the department and cross-functionally.

• Supports the growth and management of a comprehensive regulatory affairs communications program to ensure delivery of timely regulatory intelligence to a broad range of internal USP stakeholders, highlighting emerging opportunities and risks and providing an assessment of organizational impact.

• Identifies regulatory commenting opportunities and assists with the process for the drafting of comments for submission to regulatory dockets.

• Partners with Government Affairs and Public Policy to understand and monitor evolving public policy trends and work with internal stakeholders to identify opportunities and risks.

• Provides internal cross-disciplinary working groups with relevant regulatory intelligence information to inform USP positions and actions on various regulatory issues.

Basic Qualifications

Manager

• Bachelor’s degree (BS/BSc or BA), in a scientific, policy, or health-related discipline 

• Five (5) years of experience in the pharmaceutical or life sciences industries with prior experience working within or interacting with the US Food and Drug Administration (FDA)

Senior Manager

• Bachelor’s degree (BS/BSc or BA), in a scientific, policy, or health-related discipline 

• Eight (8) years of experience in the pharmaceutical or life sciences industries with prior experience working within or interacting with the US Food and Drug Administration (FDA)

Skills Sought

• 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 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

Preferred Qualifications

• Strong knowledge of USP organization, functions, and processes along with experience in compendial and product quality

• Well-developed and strong organizational, interpersonal communications, presentation, facilitation, writing, and listening skills with the ability to respond to fast changing workload. 

• 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.

• Advanced degree in law, public policy, public health, medicine, allied health, science, or other related field.

• Experience in compendial and product quality areas.

• Knowledge of the life sciences industry especially in areas of regulatory affairs, manufacturing and quality.

• Ability to influence and drive initiatives without direct authority.

• Strong critical thinking and problem-solving skills

• Demonstrated ability to work collaboratively in a matrixed organization.

• Demonstrable commitment to public health/patient safety/consumer protection, familiarity with global public health issues is an advantage.

Supervisory Responsibilities

None

Benefits

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.

About USP

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

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.