Job Details

Target PR Range: 130-150/hr

SUMMARY/JOB PURPOSE:

Leads the systematic collection, analysis, and dissemination of regulatory intelligence to proactively inform policies, processes, and practices, enabling subject matter experts to assess the impact of evolving global regulatory requirements and translate regulatory changes into actionable guidance. Accountable for the timely development, execution, and completion of regulatory impact assessments and action plans to ensure ongoing compliance and continuous improvement of processes and procedures.

Serves as a key cross?functional partner across Research & Development, Quality Assurance, Pharmaceutical Supply Chain, and Information Technology to drive consistent, enterprise?wide implementation of regulatory expectations.

ESSENTIAL DUTIES/RESPONSIBILITIES:

·       Monitor the external regulatory environment to identify emerging intelligence with relevance.

·       Identify, analyze, and proactively communicate regulatory developments, including regulatory-related news and competitor product approvals, and submissions.

·       Establish formal and informal networks to keep up to date with regulatory intelligence and interpretation.

·       Interpret regulatory intelligence to assess the impact on and advise key stakeholder and leadership accordingly.

·       Monitor organizational strategic priorities and participate in cross-departmental discussions to ensure timely identification of relevant and targeted regulatory intelligence.

·       Leads Regulatory Affairs action planning of updates to policies, processes and procedures based upon new intelligence and surveillance information.

·       Monitor the completion of regulatory intelligence-related action plans.

·       Establish cross-functional relationships and an internal network to plan impact assessments and action implementation resulting from new regulatory intelligence.

·       Business owner for the enterprise regulatory intelligence system.

·       Establish process and measures to ensure Regulatory Affairs conformance with quality procedures.

·       Support audits and inspections to demonstrate compliance.

SUPERVISORY RESPONSIBILITIES:

·       None.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

·       Bachelor’s degree in related discipline and a minimum of thirteen years of related experience; or,

·       Master’s degree in related discipline and a minimum of eleven years of related experience; or,

·       PhD degree in related discipline and a minimum of eight years of related experience; or,

·       Equivalent combination of education and experience.

Experience:

·        Regulatory Affairs and oncology experience with a pharmaceutical company required.

 Knowledge, Skills and Abilities:

·       Develops and manages plans, establishes timelines, sets standards for performance. Proactively balances commitments and overcomes challenges to complete multiple activities and achieve results. Takes pride in delivering high quality work.

·       Applies extensive knowledge of the regulatory framework, industry drivers and practices to develop innovative approaches and manage complex work.

·       Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one to one situations and effectively presents information to cross-functional groups of colleagues.

·       Strong interpersonal skills and ability to accommodate differing views to influence an agreed upon resolution.

·       Manages effectively performing teams, facilitates team alignment and achievement of common objectives. Engages internal and external stakeholders to establish productive collaborative relationships.

·       Applies knowledge of organizational goals and objectives and demonstrates advanced skill and insight in gathering, analyzing and applying key information to solve problems. Provides regulatory expertise to cross-functional teams. Understands longer term consequences of decisions and actions.

·       Effectively leads and manages a team, acting with integrity to build trust and execute on team objectives that contribute to departmental goals.

·       Capable of proactively assessing workload, trends, tasks and priorities for area of responsibility.

·       Plans and executes multiple activities.

·       Considers alternative methods and contingency plans to avoid potential issues.

·       Designs and implements solutions to address project level challenges, taking into consideration the broader impact.