SIGA Technologies, Inc. is seeking an experienced Regulatory Documentation Specialist to join the team at our location in Corvallis, Oregon. This is a full time (40 hrs/week) position and will report to the Senior Director of Regulatory Affairs. The successful candidate will be responsible for managing and maintaining all documentation to be used in applications and regulatory filings to government regulatory agencies, and for interacting with vendors used to assist with regulatory submissions. This position will coordinate with internal departments to assure documents are properly formatted and meet electronic Common Technical Document (eCTD) standards.
Responsibilities for the position include:
Responsible for managing and maintaining submission documents submitted to government agencies. Primary focus will be with the U.S. FDA, with some international work.
Responsible for managing and maintaining the Regulatory Affairs electronic or paper documentation.
Act as the primary contact with the eCTD vendor. Responsible for providing the appropriate eCTD documents to the eCTD vendor.
Maintaining version control for regulatory submission documents.
Formatting final documents with macros for appropriate cross-references and hyperlinks in the eCTD.
Testing all eCTD templates for formatting requirement conformance.
Manage the eDATA room and training in-house users and external users to ensure secure and efficient use of documents.
Training SIGA and outside vendors on the eCTD templates.
Resolve any issues identified by eCTD vendor in a timely manner. Meeting with appropriate SIGA team on any eCTD issues.
Under the direction of the Senior Director of Regulatory Affairs, help develop and provide submission content plans to eCTD vendor throughout the submission process.
Ensure that quality standards and strict deadlines with deliverables are met.
Minimum qualifications include:
Associates degree and three or more years of pharmaceutical industry experience OR; High School Diploma or equivalent and five or more years relevant experience.
Demonstrated experience with MS Office Suite with a strong proficiency in MS Word as well as Adobe Acrobat.
Demonstrated experience formatting and managing electronic and paper documentation.
Experience with pharmaceutical regulatory filings in the U.S preferred. International submission experience a plus.
Experience with eCTD format requirements and XML creation for the pharmaceutical industry a plus.
The successful candidate will possess the following knowledge and abilities:
The ability to function in a fast-paced, high-growth, entrepreneurial environment.
Strong, professional interpersonal skills including ability to communicate effectively with people both individually and in groups.
Good working knowledge of regulatory filing requirements a plus.
Demonstrated ability to work independently and take initiative in scheduling and meeting deadlines.
Is a team player who can work flexibly and enthusiastically within a small business environment.
Employer will assist with relocation costs.
Internal Number: 10042019.2
About SIGA Technologies, Inc.
SIGA is a commercial-stage pharmaceutical company focused on designing and developing novel countermeasures to prevent and treat serious infectious diseases, with an emphasis on biological warfare defense. On July 13, 2018, the United States Food & Drug Administration (FDA) approved oral TPOXX for the treatment of smallpox. SIGA is considered a leading drug development company in the biodefense arena. Its portfolio of existing drug candidates and its platform for developing additional countermeasures against potential agents of biological warfare are intended to fill a critical need for safe and effective treatments.
SIGA offers a challenging, dynamic environment with growth opportunity, competitive compensation, and a full benefits program.
SIGA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, gender identity, sexual orientation, marital status, age, national origin, predisposing genetic characteristics, unemployment status or veteran’s status and will not be discriminated against on the basis of disability.