100% Remote "Chemistry, Manufacturing and Control" (CMC) Global Regulatory Submissions

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Job description

REFERRALS APPRECIATED

$1000 Referral Fee Paid If We Place Your Referral!

100% Remote "Chemistry, Manufacturing and Control" (CMC) Global Regulatory Submissions

Project Description: Functions as a member of the Biopharmaceutical Development (BPD) Scientific Writing (SW) team and, independently with limited guidance, manages the preparation and review process of regulatory documents for the quality (CMC) modules for global submissions across early and late stage of biologics development. As a member of the SW team, coordinates and consults on regulatory filings, writing processes, and initiatives to advance the Client's pipeline and support marketed products.

• Independently with limited guidance performs the following tasks:
  • Lead or participate in managing the preparation of BLA/MAA sections with one or more BPD function.
  • Lead cross-functional teams in managing the preparation of regulatory defense for marketing application.
  • Manage CMC sections for clinical trial applications. ( CTAs )
  • Responses to questions from regulatory agencies.
  • Lead the process of critical review of development and regulatory documents and incorporating multiple internal and external reviews into quality documents.
  • May lead template and procedure preparations including stakeholder management.
  • May manage submission preparation activities for multiple projects at different development stages.

Required Skills:

• Bachelor's or master's degree in a relevant technical discipline such as biology, chemistry, biochemistry, chemical engineering, bioengineering.
• Bachelor's and 5+ years OR Master's and 3+ years of biopharmaceutical industry experience scientific discipline relevant to manufacturing and drug development of biologics products, such as cell culture, purification, analytical biochemistry, formulation, device, etc.
• Experience with electronic submission systems, editing and reviewing large documents is required.
• Technical writing experience is desirable, while experience preparing CMC regulatory documents and manuscripts is preferred.
• Experience working in a matrix environment, leading teams is preferred.
• RAC or PMP certification is desirable.
• Background in biologics such as monoclonal antibodies and/or vaccines.
• Background in biologics CMC is highly desired.
• Must have strong written and oral communication skills.
• Must have project management experience and a high level of planning and organizational skills.
• Must have strong interpersonal skills.
• Must be able to work on multiple projects.
• Must be proficient in Microsoft Office.
• Knowledge and understanding of FDA regulatory requirements and ICH guidelines.
• Experience in working with Style Guides or Authoring Tools and electronic submission systems.

If this is a good fit for you and you can work on w2,

please email your updated resume as a Word Document

to: :-)

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