Regulatory Affairs Specialist – Post Marketing
IQVIA
full-time
Posted on:
Location Type: Hybrid
Location: San Jose • United States
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About the role
- Acts as a Regulatory Team Member on small, straightforward regulatory projects and/or gets involved in a small single service project, under the guidance of senior staff;
- Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate;
- Experienced in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable;
- Prepares and/or reviews regulatory documentation in area of expertise, as appropriate;
- Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters;
- Understands the Scope of Work, deliverables for any given project;
- May prepare slides and background material for small, straightforward business development meetings under senior guidance and presents in client meetings by phone or in person;
- May prepare and deliver trainings, as appropriate;
- Performs other tasks or assignments, as delegated by Regulatory management;
- Responsible for making minor changes in systems and processes to solve problems where problems faced are not typically difficult or complex;
Requirements
- Bachelor's Degree in Lifescience or related discipline.
- At least 2 years of regulatory affairs (postmarketing) experience: maintenance records, new records, regulatory activities.
- Fluent English : Spoken, Read and Written.
- It's a plus to have worked with other countries: USA, Canada.
- Good, solid interpersonal communication (oral and written) and organization skills;
- Ability to establish and maintain effective working relationships with coworkers, managers and clients;
- Strong software and computer skills, including Microsoft Office , publishing applications and tools, as applicable;
- Demonstrates self-motivation and enthusiasm;
- Ability to work on several projects, with direction from senior staff as appropriate;
- Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements;
- Ability to make decisions on discrete tasks under senior supervision;
- Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education;
- Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area;
- Problems faced are general and may require understanding of broader set of issues, but typically are not complex;
- Applicable certifications and licenses as required by country, state, and/or other regulatory bodies.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory affairsregulatory documentationproject managementpostmarketing experiencemaintenance recordsregulatory activitiesprocess improvementsstandard operating procedurestraining deliveryproblem-solving
Soft Skills
interpersonal communicationorganizational skillsself-motivationenthusiasmeffective working relationshipsdecision-makingindependent thoughtcommunication skillscollaborationpresentation skills