SIGA Technologies, Inc. (www.siga.com) is seeking an experienced Regulatory Affairs Manager to join the team at our location in Corvallis, Oregon. The Regulatory Affairs Manager 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 Affair and is accountable for the effective management of regulatory activities associated with the development, registration and maintenance of assigned products predominantly in the United States, Canada, and Europe. The incumbent will also be a back-up liaison with the FDA and other regulatory agencies for assigned projects.
Responsibilities for this position include:
Work directly with the Senior Director of Regulatory Affairs and other project team members in determining and preparing global regulatory strategies for the development and approval of products.
Provide input on regulatory issues relating to developmental and post-marketing conditions.
Plan and coordinate documentation/data for regulatory with a primary focus on non?clinical 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.
Provide regulatory input and advice on the creation, implementation, and revision of SOPs.
Keep abreast of current regulatory environment in the U.S. and other applicable markets.
May require travel both domestically and internationally up to 10% of the time.
Minimum Qualifications include:
Bachelors degree in a scientific discipline such as Chemistry, Biology, Microbiology, or equivalent.
A minimum of seven years biotech or pharmaceutical industry experience, with five years of increasing regulatory affairs experience.
Demonstrated experience with MS Office Suite with a strong proficiency in MS Word.
Knowledge of biotech R&D and regulatory processes.
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.
Previous experience with clinical trials and assembling the clinical modules of registration documents is a plus.
Previous experience with medical monitoring and adverse event reporting is desirable.
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. Preclinical requirements knowledge a plus.
Demonstrated ability to work independently and take initiative in scheduling and meeting deadlines.
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: 10042019
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.