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10 days old

Regulatory Affairs Specialist

Kelly Services
Lawrence, NJ 08648
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Regulatory Affairs Specialist** at a prestigious Fortune 500 company working in **Lawrenceville, NJ**


**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the Submit Resume button included within.


**Job Title: Regulatory Affairs Specialist**


**Pay: $52 per hour**


**Job description:**


Support Regulatory Lead in the preparation of HA interactions (meeting preparation, rehearsals, execution, follow-up, minutes, etc.)

Maintain tracking data for health authority meetings, PMRs/PMCs, and other key regulatory milestones and liaise cross-functionally to generate periodic internal milestone reports

Provide operational support on strategic regulatory documents to help drive timely deliverables

Drive operational excellence in Global Regulatory Strategy & Policy through projects aimed to support collaboration and improve efficiency

Additional responsibilities, in conjunction with regional and/or global regulatory leads, include:

o IND, BLA, and NDA maintenance submissions

o Safety and Annual report submissions (regulatory components)

o Coordinating and driving rapid response team meetings to ensure quality and timely responses to health authority queries. This includes the preparation of response to HA queries according to the rapid response process.

o Maintaining global submission plans and supporting those plans can be executed on time

o Coordinating and driving global regulatory subteam meetings to ensure high quality meeting discussions & outputs; this includes diligent follow-up with Subteam members to uphold accountabilities and drive decision-making


**Qualifications/Requirements** :

Solid scientific background (BS, MS, PhD, PharmD).

1-3 years of pharmaceutical industry experience or related healthcare fields. Ideally 1 year in regulatory affairs or 1-2 years in a complementary functional area (eg, clinical research)

Demonstrates a high-level of self-motivation and professional commitment. Indirect management experience of people or major projects.

Ability to rapidly adapt to different issues and projects at one time. Good interpersonal skills.

Excellent communication skills.

Comprehensive understanding of the pharmaceutical industry.

Comfortable working in a fast-paced environment where speed is paramount

Willing to work as a topic expert, outside of a traditional functional environment, in a team unified around serving the assets

Ability to recognize, articulate, and accept calculated risks to make informed decisions

Willingness and ability to effectively work in a highly matrixed team environment

Develop understanding of different TAs due to assignment to different projects.

Increased understanding of the regulatory procedures (US, EU, others) and regulatory landscape.

Increased exposure to global and multi-functional teams.


**Other Qualifications** :

Strong team player with ability to seamlessly collaborate across functional and geographic boundaries to achieve companys goals

Strong attention to detail

Thrives on seeking and incorporating constructive feedback

Communicates opinions, facts and thoughts with clarity, transparency and honesty

Demonstrates ownership of results within (and beyond) area of responsibility.

Sets clear and high expectations and holds self and others accountable for decisions and results achieved.

Looks for opportunities for continuous improvement.



**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** www.kellyservices.com **.**


**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**


**Kelly Services is an Equal Opportunity Employer**


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


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 interestsits 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, 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-02-15 Expires: 2021-03-18

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Regulatory Affairs Specialist

Kelly Services
Lawrence, NJ 08648

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