Regulatory Operations Manager
SIGA Technologies, Inc. is seeking an experienced Regulatory Operations Manager 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 or Bachelors degree and five or more years of pharmaceutical industry experience OR; High School Diploma and ten or more years of pharmaceutical industry 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 regulatory documentation.
- 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 successful candidate will have demonstrated experience in the preparation and submission of regulatory filings in the U.S. and preferably experience in international submissions. NDA/eCTD submission/maintenance experience a plus.
- 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.