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27 days old

Regulatory Affairs Lead

Kelly Services
Cambridge, MA 02238
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 Lead** at a prestigious Fortune 500 company.





**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 Lead**





**Job Description**

The Global Regulatory Lead will be responsible for developing and delivering innovative, breakthrough global regulatory strategies for product development and approval, in alignment with the global business strategy. Responsible for leading a comprehensive and strategic approach to developing and executing integrated global regulatory strategies that account for the complex interplay between major Health Authorities (including US, EU, JP, and China) . Represent the company with domestic and international regulatory authorities and corporate partners. Provide regulatory support for various departments, projects, and teams/committees.





**Requirements** :



8 years pharmaceutical/biotechnology industry experience with technical management experience.

Minimum of 6 years in Regulatory Affairs.

Experience in interpretation of regulations, guidelines, policy statements, etc.

Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.

Extensive experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.

Expert knowledge with respect to the respective regulatory landscapes in the US, EU, and Japan.

Solid knowledge of GCPs and GLPs.

Direct experience in interfacing with relevant regulatory authorities (FDA, EMA, and PMDA).

Foster effective, positive interactions with regulatory agencies, and corporate partners.

Ability to lead and influence project teams, committees, etc. to attain group goals.

Demonstrate excellent leadership and communication skills.

Ability to represent the department in project teams, committees and external meetings.

Demonstrate strong organizational skills, including the ability to prioritize personal workload.

Strong interpersonal skills and the ability to deal effectively with a variety of senior personnel including medical, scientific, and manufacturing staff.

Well organized, detail oriented, effective written and oral communication skills.

Expert knowledge and experience in gene therapy highly desirable.





**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** www.kellyservices.com at http://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/non-traditional 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2020-09-02 Expires: 2020-10-08

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Regulatory Affairs Lead

Kelly Services
Cambridge, MA 02238

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