Pharmaceuticals, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
4 Year Degree
Regulatory Affairs Manager
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 Affairs. This position 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 the 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.
Responsibilities for this position include:
Work directly with the Senior Director, 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 chemistry, manufacturing, and controls (CMC) 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.
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 CMC regulatory filings in the U.S. and preferably experience in European 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 affairs, drug development, and CMC, requirements. Preclinical and clinical 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
Employer will assist with relocation costs.
Additional Salary Information: Up to $10,000 relocation reimbursement
Internal Number: 112018
About SIGA Technologies, Inc.
SIGA designs and develops novel countermeasures to prevent and treat serious infectious diseases, with an emphasis on biological warfare defense. SIGA is now 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.