Remote: Senior Director of Regulatory Affairs

Life Sciences & Technology | Regulatory Affairs

Job Description:

A Black Diamond client is seeking a Senior Director of Regulatory Affairs to drive work and develop regulatory documentation. This position will report to the VP of Regulatory Affairs and support the drug development and registration efforts for biologic products, including vaccines, antibodies, and monoclonals across different infectious diseases and therapeutic areas. This role will ensure the coordination and management of Quality/CMC regulatory documents related to all pre and post-marketing activities in all regulatory jurisdictions. Strong links need to be established with all involved other departments and external partners, as applicable, to ensure dossiers are compiled, submitted, and approved in an efficient and timely manner. This position will coordinate the overall timeline of work and collaborate with both internal and external stakeholders. Train and support other SMEs in Quality/CMC requirements within designated functional areas. Additional responsibilities include writing and/or reviewing technical Quality/CMC Regulatory documents for global regulatory submissions, ensuring compliance and alignment with global regulatory requirements and strategy. Lead special projects in coordination with internal and external stakeholders. Lead preparation and compilation of Quality/CMC portions of eCTD and non-eCTD global regulatory submissions and submission documents (may lead to the submission of delegated dossiers).

Minimum qualifications:

  • B.Sc. In a relevant field (biological or chemical sciences)
  • 7+ years of experience in regulatory affairs
  • Major submissions (e.g., INDs/CTAs, BLA/NDS/MAA)
  • RAC certification a plus
  • Excellent knowledge of global regulatory agencies, submission processes, and filing/approvals with Quality/CMC document and dossier requirements
  • Broad understanding of GLP / GMP / GCP
  • Excellent understanding of global labeling requirements and ability to find regulatory material and information

 

#LI-RL1

#LI-Remote

Remote: Senior Director of Regulatory Affairs (228168)

Start Date
ASAP
Location
Remote, United States

Apply Now