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Regulatory Affairs Manager

Kelly Services

Rosenberg, TX
Job Code:
  • Government
  • Regulatory Affairs
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Job Details

Job Title Regulatory Affairs Manager

Jobid US589HKR_BH1432035

Location: Rosenberg, TX, 77471, USA

Description **_Regulatory Affairs Manager – Southwest Houston, TX_**

**_Direct Hire!_**

Kelly Scientific Resources is currently seeking a Regulatory Affairs Manager for one of our top clients in Southwest Houston, TX.


+ Schedule and conduct internal departmental audits annually; manage audit scheduling, documentation and follow up on status of observation points.
+ Track and coordinate external audits with assistance from QA.
+ Participate in, document and prepare responses to regulatory and customer audits; prepare and obtain approval of action plans to address observations.
+ Track status of actions identified; approve solutions to observations until completion.
+ Review all labeling for accuracy and compliance; contact customers to resolve issues identified.
+ Prepare and submit all required reports and/or quota requests to DEA for controlled substances and listed chemicals.
+ Execute form DEA 222 for controlled substance orders; submit documentation pursuant to orders and properly maintain documentation as required.
+ Assist Purchasing, Production, and Quality in the management and documentation of the destruction of all controlled substances and listed chemicals.
+ Complete all other reporting documentation as required (ATF, Texas Health Department, Texas Controlled Substances, Texas Alcohol, etc.).
+ Annually review all existing Standard Operating Procedures for the Texas facility, and verify accuracy with actual current practice; submit necessary change control requests and track status of required updates.
+ Confirm accuracy of FDA Drug Listing annually; confirm labeling is compliant and current.
+ Monitor revisions and updates of regulatory references such as USP, EP, Homeopathic Pharmacopeia, Code of Federal Regulations, FDA Guidance, etc. and provide information to other departments for compliance updates to procedures.
+ Assist R&D with preparation and submittal of marketing applications.
+ Receive Adverse Event Reports, Field Alerts, etc. and implement actions and monitor progress.
+ Prepare and submit End User Letters to suppliers as required.
+ Prepare and submit all necessary documents to support product shipments to and/or from foreign countries.
+ Issue and/or review revisions to existing procedures and documentation and participate in the approval process when needed.
+ Review agreements and contracts for approval or revision; submit to the company’s Legal as required; maintain an accurate file of all current agreements and contracts; notify necessary parties when updates/renewals are due.
+ Provide guidance during investigations issuing responses and tracking status as necessary.
+ Manage any required corporate regulatory duties as needed.
+ Perform other related duties as required.

+ Bachelor’s Degree in a Life Science field.
+ 7+ years related experience in a pharmaceutical environment or equivalent combination of experience and education.
+ RACS certified preferred.
+ 5+ years of auditing experience or equivalent combination of experience and education.
+ Hands-on experience in filing and maintaining NDA's, ANDAs.
+ Experience with electronic submissions.
+ Thorough knowledge of U.S. regulatory environment required, knowledge of international environment is a plus.
+ Excellent verbal and written communication skills.
+ Ability to handle multiple high priority assignments.
+ Proven technical aptitude.
+ Advanced technical writing skills and acute attention to detail.
+ Ability to build rapport at all levels of the organization as well as with external contacts.
If you meet these specific job requirements please submit your resume for consideration.

**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 relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda 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 2017 was $5.4 billion. Visit and connectwith 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 iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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