(Senior) Regulatory Intelligence & Analysis Manager

U.S. Pharmacopeia
  • Location
    Rockville, Maryland
  • Sector
    Commercial
  • Experience
    Advanced
  • Posted
    Apr 01

Position description

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 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.

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

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

Qualifications

Manager Experience:

  • Bachelor’s degree in a scientific, policy, or health-related discipline

  • Five (5) years of related experience, or two (2) years and Regulatory Affairs Certification (RAC)

  • Or any equivalent combination of education/experience determined to be acceptable by the Human Resources Department.

Senior Manager Experience

  • Bachelor’s degree in a scientific, policy, or health-related discipline

  • Eight (8) years of related experience, or five (5) years and Regulatory Affairs Certification (RAC)

  • Or any equivalent combination of education/experience determined to be acceptable by the Human Resources Department.

Skills Sought

  • Well-developed and strong organizational, interpersonal communications, presentation, facilitation, writing, and listening skills

  • Strong thought leadership and the ability to synthesize complex information and think broadly and develop applicable strategies to align with expected outcomes

  • Ability to effectively engage with partners and support a strategic initiative or business function; 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

Preferred Qualifications

  • Prior experience working within or interacting with the US Food and Drug Administration (FDA)

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

  • Strong knowledge of FDA organization, functions, and processes. Experience in compendial and product quality areas is a plus.

  • 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.

  • Ability to influence and drive initiatives without direct authority.

  • Solution-oriented and innovative; can identify creative options for resolving issues that respond to multiple stakeholder interests and needs.

  • Strong critical thinking and problem solving skills

  • Demonstrated initiative and ability to successfully handle multiple priorities and projects in a fast-paced environment.

  • 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.

USP offers an impressive benefits package, including:

  • 100% remote working arrangements for non laboratory staff until September 2021, along with additional flex working options

  • Generous paid time off – 15 paid holidays, 10 sick days and 15 vacation days per year to start

  • An annual 401(k) contribution, beginning after 1 year of service, of 10% of pay (base and bonus) every pay period that vests immediately

  • Comprehensive individual and family healthcare plans with affordable premiums and low annual deductibles.

Application instructions

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