Associate Director, Regulatory Affairs (CMC)

Job Type: Location Type: Hybrid

 

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 global regulatory filings, assisting in the development of global regulatory strategies, and participating in project teams by providing regulatory insight within the Chemistry Manufacturing and Controls (CMC) team. In addition to a partnership with the broader regulatory team, this team member will work closely with Quality, CMC and Supply Chain. This team member will represent regulatory for RA CMC deliverables including regulatory strategy, regulatory submission component authoring and oversight, and change control assessments. This team member will ensure the planning, development and finalization of high-quality regulatory CMC documentation designed to meet global regulatory requirements.

This role is a direct report to the Senior Vice President 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, Europe, United Kingdom and Japan. Additionally, this role provides oversight and regulatory strategies for Emergency Use Authorizations and / or new registrations in other regions, as needed.

As a full-time employee, the Regulatory Affairs Associate Director 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, Quality, Supply Chain and 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 submissions, including global regulatory impact assessments for change controls and deviations.
• Working with the SVP Regulatory Affairs, develops global regulatory strategies for CMC submissions. This includes identification of differences between regions, identification of key data requirements, and development of key messages for inclusion in regulatory submission components.
• Provides regulatory submission strategy to project teams, authoring and content reviews for regulatory submission sections, assuring compliance with global regulatory standards and guidance while maintaining submission timelines to meet business objectives with a primary focus on chemistry, manufacturing, and controls (CMC)
• Prepares submissions of global registration documents (INDs, NDAs, etc.). This includes authoring and / or reviewing regulatory submission components for completeness, internal consistency with other documents, and conformance to applicable global regulations; assures readiness for submission by generation of a risk register and subsequently gathering missing information, resolve internal consistency and regulatory issues; compiles high quality submissions that meet all applicable regulatory requirements.
• Coordinates responses to CMC information requests from global health authorities
• Proactively identifies potential risks to programs and contributes to development of risk mitigation approaches in line with global regulatory expectations
• Reviews CMC-related changes for potential impact to global submissions, provides regulatory impact assessments and works across the CMC project team to ensure the changes are reported in a timely manner
• Participates in global health authority meetings, including development of the CMC strategy and associated briefing documents
• Provides regulatory CMC updates to Annual reports, Investigator Brochures and other regulatory documents as required
• Provides regulatory input and advice on the creation, implementation, and revision of SOPs.
• Keep abreast of current global regulatory environment.
• Performs other related duties as assigned

Minimum Qualifications include:

• Bachelor’s degree in a scientific discipline such as Chemistry, Biology, Microbiology, or equivalent required.
• A minimum of twelve years biotech or pharmaceutical industry experience, with at least seven years of increasing regulatory affairs experience with drug substance / drug products across phase of product development required.
• Strong leadership, collaboration and project management skills, ability to work independently, multi-task and work effectively in a fast-paced environment
• Demonstrated understanding and knowledge of biotech R&D and regulatory processes, including regulatory CMC requirements for major markets.
• Demonstrated experience writing/preparing global regulatory submissions.
• Demonstrated experience with development and execution of global regulatory strategies, with attention paid to regional requirements and differences in both pre-approval and post-approval settings.
• Experience with preparation of briefing documents, presentations and meetings with global health authority meetings desirable.
• Demonstrated experience with MS Office Suite with strong proficiency in MS Word and Adobe Acrobat.
• 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 across phases of development with demonstrated knowledge and experience in US and European and/or Canadian and/or Japanese 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 global regulatory affairs, drug development, and manufacturing practices. Good manufacturing practices (GMP) requirements knowledge a plus.
• Demonstrated ability to work independently and take initiative in maintaining timelines and meeting deadlines.
• Experience with antiviral or anti-infective drugs, especially oral capsules and injectables, a plus. Experience with small molecule products and biologics desirable.
• 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.

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.