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Pharmaceutical Regulatory Affairs Manager

Kelly Services

Bedford Heights, OH
Job Code:
  • Business Development/Operations
  • Government
  • Regulatory Affairs
  • Project Management
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Job Details

Job Title Pharmaceutical Regulatory Affairs Manager

Jobid US33YEHS_BH1398690

Location: Bedford Heights, OH, 44128, USA

Description Kelly Scientific Resources is currently seeking a Regulatory Affairs Manager for one of our top clients in Bedford Heights, OH. This is a direct hire opportunity with excellent benefits!

**Scope:** This position insures timely communication, feedback and follows up with the FDA. This role is responsible for maintaining open communication with the Director as well as with employees within department.


+ Communication with the FDA either in person, by telephone or by letters. Notify Director concerning FDA communications and application status.
+ Interpreting laws and guidance’s applicable to the development and operations, and support the rollout of these regulations within the organization.
+ Communicate regulatory strategy and implementation plan for submissions and approved applications to internal customers.
+ Review and approval of documents (batch records, specifications, analytical methods, protocols etc.) for regulatory compliance. Supervises the preparation of marketing applications and periodic reports. Reviews and authorizes marketing applications and periodic reports to meet FDA’s current requirements.
+ Support strategy to resolve deficiency questions from the Agency and path forward to complete additional activities to support responses. Work with Director to develop path forward for submission of post approval changes which comply with regulations while meeting business needs. Review Deficiency response letters and post approval supplements for appropriate wording, terminology and presentation.
+ Under the Director’s guidance, advise customers how to prepare their marketing applications with particular emphasis on sterility assurance information. This includes recommendations for regulatory strategies for submitting changes. Support continued growth by providing submission strategy for facility and equipment upgrades to meet the business needs.
+ Mainly responsible for pre-approval regulatory affairs activity. Will need to have strong knowledge of post-approval regulatory affairs.
+ Responsible for oversight of labeling program for products and contract as applicable.
+ Ensures that all of the PKPD & clinical studies necessary are conducted in a compliant and timely fashion to support approval of product. Review of clinical development plans, conduct and own/lead any necessary FDA meetings, and budgetary responsibility are also a requirement of this position.
+ Management of Compendia compliance program for timely notice and evaluation of changes as well as implementation
+ Hire, train, and develop RA Staff. Train them with most current guidelines and laws so that each Associate can perform duties independently.
+ Management of workload and duties - including close collaboration with project management on filing-to-approval timelines/cycles.
**Technical Skills** : Expertise in Pharmaceutical Regulatory and FDA process and interface. Knowledge of FD & C Acts, Title 21 CFR 312, 314, 210, 211 and 820, other current related regulations, and FDA guidelines, is required. Experience with submissions, ANDA and NDAs. Working experience in clinical/bioequivalence studies and devices.

**Soft Skills:** Strong Management, Effective Problem-Solving, Clear Communication, Highly Proactive, Decisive with Strong Interpersonal, Strategic, Commitment to Timelines.

**Education and Experience** : Pharmaceutical, Chemistry or Regulatory degree. Minimum of 6 years in regulatory with progressive management.

**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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