Affinivax Regulatory Operations Associate in Cambridge, Massachusetts
Affinivax is a Cambridge-based clinical stage biotechnology company with a novel, next generation approach to the development of vaccines and immunotherapies targeting infectious and other immune mediated diseases. This novel and highly efficient vaccine technology – called Multiple Antigen Presenting System (MAPS) – enables the high affinity binding of protective polysaccharides as well as proteins in a single vaccine, uniquely inducing a broad and protective B- and T-cell immune response.
Affinivax is currently recruiting for a Regulatory Operations professional to support Affinivax’s vaccines portfolio. The successful candidate will be self-motivated, collaborative, and have vaccine regulatory experience with a particular background in clinical development. This position will report to the SVP Clinical Development and Regulatory Affairs
Coordinate the preparation of regulatory documentation for electronic regulatory submissions and, as required, paper submissions including but not limited to Investigational New Drug Applications (INDs), pediatric plans, and annual or other periodic reports.
Coordinate the cross-functional development, review and revision, and internal approval process for documents and packages associated with Regulatory Authority submissions.
Provide advanced editing/formatting support of submission documents.
May coordinate activities with an external publishing vendor.
Communicate with Regulatory Authorities and attend meetings, as needed, to track action items.
Track and maintain communications (i.e., submissions, questions, and commitments) to/from Regulatory Authorities.
Participate as an active regulatory team member on collaborations with partners
Collaborate and communicate in matrix with Clinical Development, Safety, Labeling, Regulatory Chemistry, Manufacturing and Control (CMC), and other functional areas.
Provide support and maintenance of annual reports and quality compliance.
Build and maintain up-to-date files of relevant regulatory guidelines and precedence to support compliance with global submission regulations and guidelines.
Additional duties and responsibilities as required.
Bachelor’s degree, with at least 3 years of relevant experience in the pharmaceutical/biotech industry.
Experience compiling IND, NDA/BLA, and CTD submissions.
Understanding of eCTD submission requirements.
Excellent communication (both oral and written) and interpersonal skills.
Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects.
Strong scientific and analytical skills with attention to detail.
Prior regulatory operations experience and GCP expertise essential.
In accordance with Affinivax’s duty to provide and maintain a safe workplace that is free of known hazards, we have adopted a COVID-19 vaccine policy to protect the health of our employees and their families, our visitors, and the community at large from COVID-19. This policy requires all employees, contractors, and temporary workers, to: (1) obtain an approved vaccination and provide proof of vaccination or (2) request an accommodation for a medical or religious exemption. Our policy is based on guidance from the Centers for Disease Control (CDC) and Prevention.
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