The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
SIGA Technologies, Inc. (www.siga.com) is seeking an experienced Regulatory Affairs Specialist. This is a remote positon with a contract offered through December 2021. The Regulatory Affairs Specialist is responsible for coordinating and preparing applications and regulatory filings, assisting in the development of regulatory strategies, and participating in project teams by providing regulatory insight. This role is a direct report to the Senior Director of Regulatory Affairs and is accountable for the effective management of regulatory activities associated with the registration and maintenance of assigned products predominantly in the United States, Canada, and Europe.
Responsibilities for this position include:
Provide input on regulatory issues relating to developmental and post-marketing conditions.
Plan and coordinate documentation/data for regulatory with a primary focus on chemistry, manufacturing and controls (CMC) and/or clinical submissions.
Prepare submissions of registration documents (INDs, NDAs, etc.). Review material for completeness, internal consistency with other documents, and conformance to applicable agency regulations; assures readiness for submission by gathering missing information, resolving internal consistency and regulatory issues; compiles high quality submissions that meet all applicable regulatory requirements.
Keep abreast of current regulatory environment in the U.S. and other applicable markets.
Minimum Qualifications include:
Bachelors degree in a scientific discipline such as Chemistry, Biology, Microbiology, or equivalent.
Direct experience with small molecule or biological pharmaceutical products.
Seven years of regulatory affairs experience within the biotech or pharmaceutical industry with three years of those years demonstrating management and authoring of regulatory submissions in the U.S.
Demonstrated experience with MS Office Suite with a strong proficiency in MS Word.
Knowledge of biotech R&D and writing/preparing regulatory submissions in the Common Technical Document format.
The successful candidate will possess the following knowledge and abilities:
The successful candidate will have experience in the preparation, assessment, and submission of regulatory filings in the U.S. and preferably experience in European or Canadian submissions. 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 affairs, drug development, and clinical requirements. CMC and/or clinical requirements knowledge a plus.
Demonstrated ability to work independently and take initiative in scheduling and meeting deadlines, and providing timely follow up reports to supervisors.
Good communication skills and ability to work effectively in a remote environment.
Experience with antiviral or anti-infective drugs a plus.
Is a team player who can work flexibly and enthusiastically within a small business environment.
Internal Number: 04082021
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 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.