23 days old

Regulatory Compliance Submission Specialist

Kelly Services
Cleveland, OH 44101
Kelly Scientific Resources is seeking a senior level Regulatory Compliance Specialist to work with one of our top clients in the Cleveland area.

**Regulatory Operations Project Manager and Submission Specialist** to execute all our electronic regulatory submissions to health authorities including assisting us through a BLA/MAA/WMA filing. A Regulatory Operations Specialist offers subject matter expertise in eCTD compilation using templates, publishing tools and publishing software; review and dispatch of regulatory submissions to global Health Authorities within required timeframes. The Regulatory Operations Specialist will report to the Associate Director, Global Regulatory Operations and Project Management. In this role, primary responsibilities will be to:

+ Coordinate the planning, assembly, publishing, and submittal of regulatory submissions in eCTD format for FDA and other regulatory agencies;

+ Develop submission plans and timelines to track submissions and lead submission management project teams;

+ Format MS Word and PDF documents to create submission ready files, using StartingPoint and SmartDesk;

+ Compile and publish documents using GlobalSubmit to create eCTD-compliant submission, coordinate review of submission published output, and transmit to the regulatory agency in accordance with submission timelines;

+ Archive submissions and correspondence in accordance with SOPs;

+ Ensure completion of high-quality submissions in eCTD format in compliance with applicable regulations, guidances, and Regulatory Operations standards;

+ Maintain proficiency and expertise with the tools and processes associated with electronic regulatory submissions;

+ Support submission authors in the planning and preparation of regulatory submissions;

+ Manage submission and document review cycles;

+ Develop and implement documentation standards, templates, and procedures related to the formatting, publishing, and archiving of electronic submissions;

+ Lead other projects to support the regulatory department as assigned; and

+ Collaborate with multiple internal functional areas, external organizations, partners, and other key stakeholders.

**WE ARE OFFERING:** A competitive salary, generous benefit package including medical, dental, disability, life insurance, equity incentives and bonus structure which will be discussed with qualified candidates.


+ Bachelors degree in a scientific, pharmacy or related discipline. Masters or PhD

degree in a related field a plus;

+ 8-10 years of Regulatory Operations submission and project management experience;

+ Experience with document formatting, electronic submission requirements and publishing software concepts and tools; and

+ Experience leading projects and managing direct reports.


+ Software proficiency: MS Word, Templates, StartingPoint, Endnote, Adobe Acrobat, SmartDesk, GlobalSubmit or similar tools;

+ In depth knowledge of eCTD publishing, global submission standards, and industry trends for dossier preparation;

+ Proficient with MS Office, MS Word, Adobe, eCTD authoring tools, eCTD publishing software, document management solutions;

+ Strong skills in planning, organizing, decision-making and problem-solving;

+ Ability to adhere to deadlines and adapt to changing priorities;

+ Capable of managing multiple projects and timelines;

+ Detail oriented; well organized; quick learner;

+ Strong written, verbal and interpersonal communication skills;

+ Service oriented, team player;

+ Ability to problem solve and troubleshoot; and

+ Ability to work independently under general supervision.

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 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 careerconnect with us today.

**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/nontraditional 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at
Posted: 2019-10-25 Expires: 2019-11-25

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Regulatory Compliance Submission Specialist

Kelly Services
Cleveland, OH 44101

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast