- Job no: 42327
- Category: Regulatory Affairs
Associate Director, Regulatory Affairs (CMC) SIGA Technologies, Inc. (www.siga.com) is seeking a full-time (40 hours/week) Associate Director, Regulatory Affairs (CMC) to join the Research & Development team based in Corvallis, Oregon. The Associate Director, Regulatory Affairs 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 within the Chemistry Manufacturing and Controls (CMC) team. This role is a direct report to the VP, Drug Development & Technical Operations and in partnership with the Director of Regulatory Affairs, 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. As a full-time employee, the Regulatory Affairs Manager is eligible for SIGA’s full benefits package including company paid medical, dental and vision benefits, short and long-term disability, life and AD&D insurance and paid time off. This position has the option for a hybrid office or remote work arrangement and may require domestic and international travel up to 10% of the time. Responsibilities for this position include: • Works closely with the CMC team, Regulatory Affairs team and other project team members in determining and preparing global regulatory strategies for the development and approval of products. • Provides input on regulatory issues relating to developmental and post-marketing conditions. • Plans and coordinates documentation/data for regulatory with a primary focus on chemistry, manufacturing, and controls (CMC) submissions. • Prepares 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. • Provides 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. • Performs other related duties as assigned Minimum Qualifications include: Bachelors degree in a scientific discipline such as Chemistry, Biology, Microbiology, or equivalent required. A minimum of seven years biotech or pharmaceutical industry experience, with five years of increasing regulatory affairs experience with drug products required. Demonstrated experience with MS Office Suite with a strong proficiency in MS Word and Adobe Acrobat. Working knowledge of biotech R&D and regulatory processes. Demonstrated experience writing/preparing regulatory submissions. International submission experience a plus. eCTD submission/maintenance experience required. 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 and/or Canadian submissions. • 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 manufacturing practices. Good manufacturing practices (GMP) requirements knowledge a plus. • Demonstrated ability to work independently and take initiative in scheduling and meeting deadlines. • Experience with antiviral or anti-infective drugs, especially injectables, a plus. • Is a team player who can work flexibly and enthusiastically within a small business environment. • Must be able to maintain confidentiality and manage sensitive situations with tact, professionalism and diplomacy. About SIGA: SIGA Technologies, Inc. is a public, commercial-stage pharmaceutical company focused on providing solutions for unmet needs in the health security market that comprises medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) threats, as well as emerging infectious diseases. The company is headquartered in New York City, with research and development facilities in Corvallis, Oregon. In July 2018, the U.S. Food and Drug Administration (FDA) approved SIGA’s first product, oral TPOXX® (tecovirimat), for the treatment of smallpox. Oral TPOXX is a novel small-molecule drug that has been delivered to the U.S. Strategic National Stockpile (SNS) under the Project BioShield Act of 2004 (Project BioShield). SIGA offers a challenging, growth-oriented environment with competitive compensation and a full benefits program.
- Published on 04 Aug 2022, 12:42 PM