21 days old

Regulatory Operations Specialist

Kelly Services
Gaithersburg, MD 20898
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 Operations Specialist** at a prestigious Fortune 500 company working in **Gaithersburg, MD.**

**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 ( ) however your resume must be received via the Submit Resume button included within.

**Job Title: Regulatory Operations Specialist**

**Pay: $35 per hour depending on experience**

***Position will begin remote and transition onsite once site restrictions are lifted.**

*Looking for a candidate with Regulatory exp, CMC Chemistry Manufacturing Controls and BLA Biologic licenses Application

Functions as a member of the BioOperations Submission Management (SM) team within Global Technical Operations (GTO) and, working with BPD and BioOperations scientists, manages the preparation and review process of regulatory documents for the quality (CMC) modules. As a member of the SM team, coordinates and consults on regulatory filings and writing processes; identifies and promotes initiatives to advance the biologics pipeline and support marketed products.

**Job Description**

Responsible for BLA/MAA delivery and life cycle management working within Global Technical Operations

Provide submission related expertise

Lead the process of critical review of regulatory documents and incorporating multiple internal and external reviews into quality documents

Manage SM activities associated with multiple projects: delivery of documents to submission ready standards

Participate or lead template and procedure preparations

Participate in SM-related workstreams within and across departments

Assists in providing ANGEL business support and training to BioOperations network

Lead or participate in process improvement initiatives.

Work with Reg CMC, BPD Submission Management ensure seamless transfer of submission management responsibilities for post approval submissions and Wave 2+ markets

Assist with digital uplift initiatives


Experience in pharma industry

Experience with regulatory submissions, eCTD, submission ready standards

Experience with document management systems

CMC and post-approval lifecycle document management a plus

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

**_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.
Posted: 2020-09-04 Expires: 2020-10-15

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Regulatory Operations Specialist

Kelly Services
Gaithersburg, MD 20898

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