Regulatory Affairs Writer Consultant - 229545

We are looking for an individual with strong Regulatory experience, specifically in authoring submissions throughout the product life cycle.

• 100% Remote
• 6 month contract to potential hire
• 40hrs per week

Summary:

This position supports regulatory service projects by providing by preparing regulatory submissions covering drug products, biologics, and combination products. This position involves assisting in planning as well as hands-on responsibilities.

Responsibilities:

• Prepares US and EU regulatory submissions (IND/NDA/BLA/ MAA/IMPD), meeting briefing books, clinical trial protocols and applications, and other submissions for regulatory authorities under the guidance of the regulatory strategy lead.
• Performs literature searches and generates literature summaries, as directed by the regulatory strategy lead.
• Supports the regulatory strategy lead to perform regulatory assessments.
• Performs searches and review relevant Summary Basis of Approval to support regulatory strategy building activities.
• Provides medical and regulatory writing support for all departments.
• Supports the regulatory strategy lead for activities requested by the product development teams.
• Reviews relevant FDA and other regulatory authority guidelines to support regulatory and medical writing in submissions.

Requirements:

• Bachelor’s and Master’s degree or other advanced degree in regulatory affairs or science-related field.
• 2 years’ regulatory experience in the US pharmaceutical, or combination products industry.
• Demonstrated experience of preparing US FDA/EU EMA submissions (eg, IND/NDA/BLA/MAA/IMPD), including eCTD Module 2 or Module 5 Integrated Summary of Safety and/or Efficacy.