Kelly Science & Clinical is currently seeking a Remote Sr. Regulatory Affairs Specialist for a short-term engagement with one of our Global Pharma clients out of New Jersey
***This role is remote ***
This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
Regional Strategic Implementation (RSI) is part of the Regional Regulatory Affairs organization within Global Regulatory Affairs and supports regulatory activities in Asia Pacific (AP), Latin America (LA) and the Emerging Markets of EMEA. The team efficiently and effectively executes regional strategies and leverages processes and resources across all regions. We are therapeutically aligned and support the full lifecycle of products in all therapeutic areas.
Scope of Responsibilities:
The Sr. Regulatory Affairs Specialist, Regulatory Strategic Implementation (RSI) will:
For Marketing Authorization Applications, provides regulatory support throughout registration process and life-cycle management (e.g. iCTDs, ACTDs, renewal applications, Health Authority Responses, site registrations and routine marketed product submissions including PSURs, RMPs).
Advises team on required documents in preparation of submissions as assigned in collaboration with RSI Lead.
Assists with timely registration dossier availability, ensures that all document components are in place on time, identifies and tracks critical path activities.
Compiles Module 1 for iCTDs to be dispatched to countries.
Manages and tracks the assembly of country-specific submission packages to the LOCs in accordance with agreed plans.
Participates in Working groups to ensure timely regional and local input into product objectives, to align regions with CDT/Global strategy.
Interacts with the regional teams and Local Operating Companies to support regional and local activities.
Drafts and reviews document content (depending on level of regulatory knowledge/expertise);
Provides input to documentation to ensure they are in line with product strategy and thoroughly and accurately answers the questions being posed;
Identify and initiate on-going continuous process improvement opportunities with end users responsible for data entry and/or data consumption.
Advises team on required documents in preparation of Clinical Trial Applications (CTA)
Provides operational support for the assembly and distribution of submissions ( e.g., CTA for China, Health Authority Responses).
Support projects related to improved system functionality or to develop new business capabilities.
Responsible for the critical review of submission documents to ensure compliance with regulatory requirements.
Provides regulatory support for and appropriate follow-up to inspections, audits, litigation support and product complaints (depending on level of regulatory knowledge/expertise).
Serves as the Regulatory representative on specific multi-discipline teams.
Keeps abreast of current and pending approvals in specific therapeutic areas and is knowledgeable of laws, guidance and requirements related to those areas.
Contributes to process improvement initiatives within and across functions.
A B.A./B.S. in science/relevant health-related discipline with a minimum of 4 years of relevant experience.
Basic understanding of the product and registration life cycle from global regulatory affairs, local operating company or affiliates, and submission process perspectives is required.
Knowledge of external factors (standards, regulatory requirements) that impact Product & Lifecycle Registration is preferred.
Previous experience liaising with local, regional, and central regulatory users to ensure that new and ongoing regulatory requirements are reflected in the system configuration, functionality and business processes is highly preferred
Demonstrated ability in working in global project teams in a matrix environment across multiple projects is required.
Demonstrated ability to handle multiple projects.
Excellent English verbal and written communication skills.
Must have experience developing and maintaining strong relationships.
Must have strong collaboration skills in order to partner effectively across other business units.
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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