Senior Ra/Medical Writer

Remegen Biosciences Rockville , MD 20850

Posted 7 days ago

Were seeking a highly motivated, self-driven, and enthusiastic Regulatory Affairs writer to join our Regulatory Affairs Team. At RemeGen, our regulatory affairs group is responsible for drafting and reviewing eCTD modules (including nonclinical and clinical) for submission of US FDA and EMA. This role requires you to interact across all the development functions of RemeGen. This role is based at our site in Rockville/MD.

Write and review eCTD modules (including nonclinical and clinical), ensure CMC dossiers meeting ICH format and content requirements, as well as specific local requirements of individual countries.

Build and manage relationships through active partnering with key internal and external cross-functional stakeholders, which include process development, analytical development, manufacturing, quality control and quality assurance.

Understand, interpret and advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new pharmaceutical products, to expedite submission, review and approval of global applications.

Stay current with regulatory requirements and initiate process improvements as appropriate.

Maintain high quality standards and seek to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment

Requirements

  • Bachelor's degree in a relevant scientific discipline, MS or PhD degree preferred with minimum 5 years of relevant Biologics development experience in Regulatory Affairs.
  • Demonstrated writing skills for biologic drugs and track record of successful IND and BLA submissions to FDA and/or other health authorities, including EMA.
  • Experience in drug development, market applications and commercial lifecycle is required.
  • Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.
  • Excellent interpersonal, verbal and written communication skills as well as the ability to effectively lead and influence others are essential in this collaborative work environment.
  • Experience of recent regulatory submissions for injectable products
  • Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives.
  • Multiple languages ability is preferred, but not required.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
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Senior Ra/Medical Writer

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