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13 days old

Regulatory Affairs Specialist

Kelly Services
Raritan, NJ 08869
**Regulatory Affairs Specialist- Raritan, NJ**



**Contract Length: 12 months W2**



Provides support to the Regional Strategic Implementation Leader (RSIL) and Regulatory Regional Leader (RRL) for regulatory activities for products in the assigned portfolio. Key responsibilities include the following:


1. Input in development, post-approval and life cycle management

Participates in Working groups to ensure timely regional and local input into product objectives, to align regions with CDT/global strategy.

Advises the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned;

Develops an understanding of the regional regulatory environment, competitor intelligence and therapeutic area.


2. Interaction with the Regional groups and Local Operating Companies

Works with the regional staff and LOCs to support regional and local activities;

Assists in the preparation of meetings with Regulatory Agencies.


3. Input in document and process development

Assists in the development of processes related to regulatory submissions;

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;

Tracks dates of submissions and Regulatory Agency responses.


4. Clinical Trial Applications (CTA)

Advises team on required documents in preparation of CTAs;

Provides operational support for the assembly and distribution of submissions ( e.g., Clinical trial applications for China, Health Authority Responses);

Ensures CTA submission packages are complete and available according to agreed timelines.


5. 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;

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.


6. General

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.



**Apply Now!**



This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must submit your resumes. Thank you for your interest in the assignment.



**Also, feel free to follow up via email to RACS113@KELLYSERVICES.COM**






**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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. 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2019-11-01 Expires: 2019-12-02

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Regulatory Affairs Specialist

Kelly Services
Raritan, NJ 08869

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