Kelly Services Regulatory Affairs Specialist I, Torrance, CA in Torrance, California
Regulatory Affairs Specialist I, Torrance, CA
Job Summary: The Regulatory Affairs Specialist I is responsible for assisting with the preparation of submissions to national and international regulatory agencies. This includes the preparation of drug master files submissions and amendments, annual reports, and any related correspondence and letters of authorization.
Salary: open depending on experience
Essential Duties and Responsibilities:
Assist with compilation of drug master files for active pharmaceutical ingredients (APIs) and other substances
Prepare annual reports for regulatory submissions
Maintain records of regulatory submissions and associated letters of authorization
Maintain records of correspondence with regulatory agencies and customers related to regulatory submissions
Assist with DMF amendments
Assist with technical data packages for active pharmaceutical ingredients and other substances for use by customers in the preparation of their own submissions
Bachelor's Degree in Science related field (Chemistry, Biology or equivalent)
One (1) - two (2) years of experience in cGMP manufacturing, Quality Control (QC), or Quality Assurance (QA)
Technical writing experience
Excellent written and oral communication skills
Basic computer knowledge, including Microsoft Word, Excel, PowerPoint and Access
Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
Detail oriented with the ability to troubleshoot and resolve problems
Ability to work independently and manage one's time
Communicate effectively and ability to function well in a team environment
This position requires the employee to regularly stand, walk, sit and talk or hear. The employee must also be capable of writing, using a computer keyboard, telephone and related office equipment. The ability to lift up to 25 lbs. is required.
The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Within the facility, the employee will experience normal office conditions with a well- lighted work area and minor noise from standard office equipment. Occasionally the employee will experience unpleasant odors from the manufacturing facility. On occasion, the employee may visit the manufacturing facility several times.
Lab coat and goggles will be required for these visits. The employee may be exposed to laboratory hazards. Occasionally, the employee will be called upon to address emergency situations.
For immediate consideration, apply today! Questions? Call Airika at 562.207.2707
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 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 career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm