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Regulatory Affairs Specialist - CMC

Company: Kelly Services
Location: Emeryville
Posted on: June 15, 2019

Job Description:

Regulatory Affairs Specialist - CMCPRIMARY PURPOSE OF POSITION:

Responsible for the coordination and preparation of CMC document packages for Health authority submissions; Manages regulatory CMC activities for specific projects/products (including development, pre-market registration and approval/post approval activities); and may directly interact with regulatory agencies

MAJOR DUTIES OF POSITION:--??



  • Coordinate, compile, and review CMC package of IND and NDA submissions along with amendments and supplements.

  • Coordinate manufacturing change request evaluation by identifying required content to ensure compliance in meeting global regulatory requirements

  • Author and/or review CMC documentation for Health Authority submissions.

  • Monitor and improve regulatory compliance/tracking systems.

  • Interact with regulatory agencies on discrete projects.

    KNOWLEDGE AND SKILL REQUIREMENTS:



    • Undergraduate degree in a scientific discipline; plus 1 or more years of regulatory CMC experience preferred

    • Knowledge of global regulatory requirements and experience in regulatory submissions, approvals, and product life cycle management preferred

    • Working knowledge of US regulations and guidelines for CMC required

    • Pharmaceutical industry experience in drug development with a focus on the regulatory CMC processes preferred

    • Experience compiling INDs, NDAs and document packages for commercial products required,

    • Excellent verbal and written communications skills required

    • Knowledge of regulatory CMC support requirements for pre-approval inspections highly recommended

    • Ability to communicate effectively across all organizational levels

    • Independently motivated, detail oriented and good problem-solving ability

    • Must be able to work effectively in a fast-paced work environment, managing multiple priorities and tasks.

      Why Kelly--?

      With Kelly, youll have access to some of the worlds highest-regarded scientific organizations

      providing 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 95 of the Fortune 100 companies, and found opportunities for more than 9,000

      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 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 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.

Keywords: Kelly Services, San Francisco , Regulatory Affairs Specialist - CMC, Other , Emeryville, California

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