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Kelly Scientific Resources

Regulatory Affairs Manager

Post Date:Dec 26, 2017Type:Full-Time
Start Date:12/26/2017Salary:
Location:US-OH-Cleveland Job Reference:US33YEPG_BH1382873
Skills:
 

Job Description:


Kelly Scientific is looking for a Pharmaceutical Regulatory Affairs Controller for a direct hire opportunity with one of our valued customers near Cleveland, Ohio





Responsibilities:




  • manage and execute all electronic regulatory submissions to health authorities

  • Exhibit strong leadership through BLA/MAA/WMA filings.

  • Offers subject matter expertise in eCTD implementation through appropriate submission application installations in the following areas:

    • electronic data management system eDMS

    • templates

    • publishing tools and publishing software

    • regulatory project management.



  • Manage and coordinate the planning, assembly, publishing, and submittal of regulatory submissions for the FDA and other regulatory agencies

  • Manage regulatory projects and activities to meet submission timelines and document requirements

  • Collaborate with multiple internal functional areas, external organizations, and other key stakeholders

  • Provide leadership in global submission strategy

  • guide regulatory staff and colleagues in implementation of these strategies

  • submit successful regulatory filings up to, and including licensure applications

  • Manage staff effectively to ensure milestones and service levels are met, including workload balance and day-to-day workflow

  • Train Regulatory Operations support staff on eCTD guidelines and regulatory directives

  • Oversee the development of the Regulatory Operations team,

  • develop awareness of regulatory mindset among other employees

  • Ensure development and/or control of regulatory required document management tools

  • manage the implementation and ongoing enhancement of regulatory document compliance for electronic eCTD document management platforms and regulatory document control

  • Develop and manage internal Standard Operating Procedures SOPs and processes

  • work closely with IT and external vendors to ensure an updated and validated eCTD document management and regulatory document control platform

  • Maintain up-to-date knowledge of guidelines and regulatory directives 

  • Perform QC on submission packages to ensure completion, correctness, navigability, and adherence to regulatory eCTD guidelines.





QUALIFICATIONS:




  • Bachelor s degree in a scientific, pharmacy or related discipline.

  • Master s or PhD degree in a related field a plus

  • Minimum of 8-10 years of Regulatory Operations experience, with at least 1 lead eCTD BLA or NDA successful filing

  • In-depth knowledge of eCTD submission regulation/guidance

  • Experience with MS Office, Adobe, eCTD publishing software systems, document management solutions, and publishing database software systems

  • Proficiency in process and technology integration, with a focus on process improvement

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

  • Highly interactive interpersonal and management skills

  • Extensive knowledge of eCTD publishing systems, EDMS technology, publishing tools, global submission standards, and industry trends for dossier preparation

  • Experience in implementing principles of project management is a plus, and a proven ability to work under pressure and adhere to deadlines

  • Creative out of the box thinker who can function autonomously with little supervision to establish a state-of-the-art regulatory operations functionality is a major plus. 





Apply today or refer a friend!





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.



About Kelly 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.





Contact Information
Kelly Scientific Resources
Name: Paul Gambon


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