Vice President Regulatory Affairs

The Vice-President Regulatory Affairs (RA) is responsible for ensuring that compliance is being upheld for Regulatory Affairs at SAB Biotherapeutics (SAB). This role will lead preparation, review and submission of documents to FDA and ex-US health authorities to support product development of new biologics and regulatory and compliance aspects through the drug product lifecycle. The incumbent must be able to combine knowledge of scientific, regulatory, and business issues to ensure products are developed and manufactured according to regulations related to the manufacturing and distribution of biologics. This position manages and prioritizes RA team work on all required interim and final BLA and MAA submissions. The incumbent will regularly work cross-functionally with Clinical Development/Pharmacovigilance, Manufacturing/CMC, Quality, Medical Affairs and Commercial Readiness teams to ensure regulatory objectives align with corporate strategy and deliverables. 

Key Responsibilities (include but are not limited to):

• Provide efficient and effective regulatory representation across the organization and act as the liaison in interactions and communications (meetings, phone calls, etc.) with the Food and Drug Administration (FDA) as needed. Prepare summaries of meetings for inclusion in regulatory archives.
• Provide guidance for, and actively contribute to, the development of regulatory submissions, which may include Investigational New Drug (INDs) applications, briefing documents, orphan drug applications, breakthrough designations, Emergency Use Authorization requests and Biologics License Applications (BLAs), ensuring that they meet current regulatory requirements and industry standards.
• Provide regulatory leadership for outsourced manufacturing, including tech transfer, process validation, site transfers, comparability strategies,  lifecycle CMC changes, and global submissions.
• Assess acceptability of quality, preclinical and clinical documentation for regulatory submissions.
• Identify and develop new company regulatory policies, procedures and SOPs and general trainings for Executives and Upper Management and more specific trainings for regulatory staff.
• Develop regulatory strategy plans with specific deliverables and timelines and integrate business and clinical objectives with regulatory requirements.
• Manage inspections and audits by regulatory authorities and accompany inspection team(s) as required. Provide input for follow-up to inspections and audits to minimize potential findings of non-compliance.
• Oversee labeling, advertising, and promotional material review to ensure regulatory compliance.
• Develop, implement, and manage appropriate SOPs and systems to track and manage product-associated events including reporting of adverse events and providing input for product recalls and recall communications.
• Review change controls to determine the level of change and consequent regulatory submission requirements.
• Ensure compliance with all regulatory reporting requirements, including annual and periodic reports and maintain annual licenses, registrations, and listings through active and hands-on  management
• Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory impact and risk and identify filing strategies.
• Regular cross-functional collaboration to ensure regulatory strategy, filings and compliance activities are aligned with corporate objectives and development timelines.
• Independently provide phase-appropriate strategic guidance/input related to current regulatory requirements and expectations for INDs and BLAs for development projects.
• Provide regulatory leadership for regulatory risk assessments, scenario planning, and decision‑support to guide development strategy, program prioritization, and corporate milestones. 
• Participate in due diligence activities, as required.
• Partner with the SVP RA/QA to develop and implement the infrastructure needed to grow for Regulatory Affairs and Quality Assurance
• Collaborate with Quality Assurance to define, assess, and strengthen process controls across GxP operations, ensuring that manufacturing, testing, and quality system processes meet regulatory expectations and support inspection readiness.

Supervisory Responsibilities:
This position has supervisory responsibilities.

Education/Experience/Skills:

• Bachelors’ degree in scientific field/healthcare/regulatory discipline required.  Advanced degree in relevant field is preferred
• 15+ years of RA roles with increasing responsibility within regulatory affairs at one or more biopharmaceutical/pharmaceutical companies. Must have experience interacting with FDA, EMA, and MHRA.
• Proven leadership experience in the establishment of INDs and approvals of BLAs. Must have NDA, BLA, and MAA filing and approval experience
• Demonstrated knowledge of biologic manufacturing processes, GMP principles, and related FDA and ICH regulatory requirements
• Demonstrated experience in chemistry and manufacturing controls (CMC) and clinical issues and filings, including technology transfer, comparability, process validation, manufacturing changes, lifecycle management, and global regulatory submissions for biologic products.
• Demonstrated experience leading regulatory aspects of outsourced manufacturing and third-party CDMO partnerships, including technology transfer, CMC lifecycle management, manufacturing process and site changes and successful regulatory submissions.
• Management expertise and proven experience leading and developing high performance teams.
• Ability to work effectively across teams, functions and with outside partners.
• Familiar with US and International regulatory markets.
• A strong team player with a passion for science and helping discover and develop novel therapies for unmet medical needs.
• Excellent written and verbal communication skills. Must be proficient in Microsoft Office software (Word, Excel, PowerPoint, and Outlook).
• Ability to effectively present information in one-on-one, small groups and lab meetings.

Physical Demands
While performing the duties of this job, the employee is regularly required to walk, stand and sit.  The employee must regularly lift and/or move up to 10 pounds.  Specific vision abilities required by this job include close vision, peripheral vision, and the ability to adjust focus. 

Working Environment and Travel:

• Normal home office environment as well as on-site in SAB office location in Sioux Falls, SD.
• Regular travel to SAB location and other sites/locations as needed. Travel to the Sioux Falls facility projected at 1-2 weeks onsite per month initially followed by a regular cadence to the facility as needed.

ADA
The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.

SAB BIO is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB BIO is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets