Regulatory Affairs Manager

SIGA Technologies, Inc. (www.siga.com) is seeking an experienced Regulatory Affairs Managerto join our growing Regulatory Affairs team in Corvallis, Oregon. 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, Europe, and United Kingdom. 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. The incumbent will also be a back-up liaison with the FDA and other regulatory agencies for assigned projects and may require travel both domestically and internationally up to 10% of the time. As a full time (40 hours/week) position, this role is eligible for SIGA’s full benefits package including company paid medical, dental, and visions benefits, short and long-term disability, life/AD&D insurance and paid time off. This position is eligible for a hybrid work arrangement or remote employment for well qualified candidates.

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, while assisting with quality 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.

· Performs other duties and special projects as assigned

Minimum Qualifications include:

Bachelor’s degree in a scientific discipline such as Chemistry, Biology, Microbiology, or equivalent with at least seven years of biotech or pharmaceutical industry experience including five years of increasing Regulatory Affairs experience.

Demonstrated experience with Microsoft Office Suite with a strong proficiency in Microsoft Word.

Knowledge of biotech R&D, regulatory processes, and clinical trials.

Demonstrated experience writing/preparing regulatory submissions.

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, UK, and/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.

· Must be able to maintain a high level of confidentiality and manage sensitive situations with tact, professionalism and diplomacy.

· 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.

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.

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.

Job Type: Full-time

Pay: $115,000.00 - $125,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Relocation assistance
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Bonus opportunities

Application Question(s):

• Briefly describe your experience working on drug applications (writing and/or submitting).

Education:

• Bachelor's (Required)

Experience:

• Pharmaceutical Regulatory Affairs: 5 years (Required)
• Clinical Research Regulatory Affairs: 1 year (Required)

Ability to Relocate:

• Corvallis, OR 97333: Relocate with an employer provided relocation package (Preferred)

Willingness to travel:

• 25% (Required)

Work Location: Hybrid remote in Corvallis, OR 97333