Job Description

Reporting to the Senior Manager, Regulatory Affairs, the Regulatory Affairs Associate will have solid experience within CMC to aid in the development of the RA needs and support the Director with current programs. This role assists in compliance with current FDA and global regulatory requirements and guidelines, aligning with the company's objectives and the Quality System's goals.

Note: This is a Remote, home based role in the US.

Duties and Responsibilities (include but are not limited to):

· Manage SAB Biotherapeutics Inc.’s existing programs and facilitate the development of new programs (as needed) with the support of the Director

· Analyze requirements specified by FDA pertaining to needed submissions

· Review health authorities’ requests

· Monitor and report progress of the program operations, identify risks, highlight issues, seek input/approval from the Director

· Review IND’s, CTR’s, CTA’s, CTN’s, and Briefing Books, highlighting any major gaps in the submission documents

· Independently manage some of the product applications (Prepare CMC documents for registration submissions, such as INDs, Amendments, Supplements and Annual Reports)

· Provide CMC support throughout the lifecycle of products in a timely manner to the RA department

· Maintain and update various regulatory databases to ensure accuracy of information

· Risk Management: Develop and implement risk management strategies related to product quality and regulatory compliance.

· Regulatory Liaison: Act as a liaison with regulatory agencies during inspections and audits. Ensure timely and effective communication and resolution of any findings.

· Documentation and Reporting: Ensure accurate and comprehensive documentation of all RA activities (e.g. healthy authority communications, upcoming submissions, etc.)

· Stakeholder Collaboration: Collaborate with cross-functional teams, including R&D, Manufacturing, Quality Assurance and Quality Control to ensure alignment on quality standards and objectives.

· Other duties or responsibilities as assigned

Experience/Skills/Education:

· Bachelors’ Degree in a scientific field and minimum 2 years CMC required

· A deep appreciation of FDA requirements and key processes

· Knowledge of current FDA/EMA/MHRA/TGA regulations and guidance

· Exhibit knowledge on CMC and aspects of regulatory submissions

· Knowledge and understanding of pharmaceutical product development and regulatory requirements for product development and approval for USA region as well as life cycle management of products

· Preferred experience in reviewing, authoring, or managing components of regulatory submissions

· Solid understanding and knowledge on US FDA and ICH guidance

· Able to successfully interpret and apply regulatory intelligence to work output

· Hands-on experience within an eCTD publishing program and proficiency in pertinent software and tools

· Experience in working with cross‐functional teams and with multiple stakeholders

· Demonstrates acceptable skills in managing and adhering to timelines, negotiation skills, integrity and adaptability

· Excellent verbal and written communication skills

· Demonstrated ability to learn & process new information quickly

· Attention to detail and quality

· High degree of demonstrated proficiency with Excel, Word and PowerPoint

Working Environment:

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.

Home office environment. Minimal travel is expected and is dependent upon program needs. Occasional travel to corporate office may also be expected, 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 

 

Job Tags

Full time, Work at office, Remote work, Work from home, Home office,

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