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1+ months

Director, Regulatory Affairs

Kelly Services
Summit, NJ 07901
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 an **Director, Regulatory Affairs** at a prestigious Fortune 500 company working in **Summit, 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: Director, Regulatory Affairs**


**Pay: $250 per hour**


**Responsibilities** :


Develop and implement global regulatory strategy for assigned projects, along with Regional Regulatory Affairs representatives and Regulatory CMC.

Lead global and/or regional regulatory team on assigned projects.

Develop and execute US regulatory strategy and contingencies for assigned projects.

Serve as the primary interface for FDA on assigned projects.

Lead the preparation of submissions, which may include INDs Briefing Documents, Orphan Drug Applications, and Marketing Applications etc. Work with functional groups to define contributions to submissions. Lead regulatory submission teams for projects assigned.

Prepare company team for FDA and other health agency meetings, as required.

Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions.

Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Teams and Study Teams.

Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidance.

Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.


**Skills/Knowledge Required** :

Bachelors in scientific discipline: 7-10 years pharmaceutical industry experience, with 5-7 years in regulatory. Advanced degree preferred.

Experience in multiple phases of development in various therapeutic areas. Experience in inflammatory and immune diseases a plus.

5-9 years pharmaceutical industry experience, including 3-5 years in regulatory affairs. Global experience desired.

Thorough knowledge of the drug development process, IND and NDA process.

Demonstrated experience in preparing FDA submissions.

Inter-dependent partnering skills, team-oriented and ability to influence outcomes are necessary skills in the environment.

Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.

Must be able to innovate, analyze and solve critical problems with minimal supervision and attention to detail.

Domestic and occasional International travel may be necessary.


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

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Posted: 2021-03-15 Expires: 2021-05-17

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Director, Regulatory Affairs

Kelly Services
Summit, NJ 07901

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