Regulatory Affairs Specialist, Biologics

Requisition Number: 67375

Corning is vital to progress – in the industries we help shape and in the world we share.

We invent life-changing technologies using materials science. Our scientific and manufacturing expertise, boundless curiosity, and commitment to purposeful invention place us at the center of the way the world interacts, works, learns, and lives.

Our sustained investment in research, development, and invention means we’re always ready to solve the toughest challenges alongside our customers.

As a leading developer, manufacturer, and global supplier of scientific laboratory products for 100 years, Corning’s Life Sciences segment collaborates with researchers seeking new approaches to increase efficiencies, reduce costs and compress timelines in the drug discovery process. Using unique expertise in the fields of materials science, surface science, optics, biochemistry and biology, the segment provides innovative solutions that improve productivity and enable breakthrough discoveries.

Role Summary

Regulatory Affairs Specialist (biologics focused) provides necessary support to regulatory affairs department in many areas including regulatory filings, promotional material review, label review, knowledge of regulations, standards, regulatory policies and procedures, customer enquiries, regulatory related documentation required for export/import, post market review & assessment and training. The position requires interaction with individuals in various areas of Corning Life Sciences including business teams, manufacturing, supply Chain, technical expert/filed applications, and R&D to assure that customers’ needs are met.

Key Responsibilities

• Coordinate efforts associated with the preparation of regulatory documents or submissions for domestic and international projects.
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents related to biological products (animal derived material).
• Coordinate with cross-functional teams for maintenance of technical files and certificate of suitability filing with EDQM.
• Ensuring compliance with applicable global legislative and regulatory requirements at each stage of product development.
• Current understanding of FDA and rest of world compliance trends in Regulatory Affairs as relates to biological products, medical device, IVDs etc.
• Maintain list of medical devices and GUDID database for US UDI.
• Support internal or external audits and health agency inspections.
• Develop and/or conduct employee regulatory training.
• Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
• Analyze product complaints and perform activities for MDR and Vigilance.
• Coordinate recall or market withdrawal activities as necessary.
• Compile and prepare documents for Drug Master File (DMF)/ Master File (MFs) submission for different regions across the globe.
• eCTD technical, formatting and publishing knowledge for regulatory agency submission.
• Create or update SOPs in response to changes in regulations or standards.
• Provide support for maintaining technical files as necessary.
• Review product promotional materials, labeling, specification sheets, or test methods for compliance with applicable regulations and policies.
  
  

Requirements

• Bachelor’s degree minimum with 2 years of experience in biology, chemistry, or relevant life-sciences discipline.
• Master’s degree with 1 years of experience in biology, chemistry, or relevant life-sciences discipline.
• Experience and understanding of FDA and global compliance trends related to biological products, including media and serum, medical devices, IVDs and more
• Knowledge of Biological license application (BLA).
• Experience with certificate of suitability (CEP) for EDQM submissions.
• Preferred knowledge of Drug master file (DMF) and eCTD technical submissions.
• Experience with FDA 21 CFR 820, ISO 13485, and ISO 9001.
• Proficiency with Microsoft Office tools, eCTD software, Adobe Acrobat, and working knowledge of QMS systems.
  
  

This position does not support immigration sponsorship.

The range for this position is $66,478.00 - $91,407.00 assuming full time status. Starting pay for the successful applicant is dependent on a variety of job-related factors, including but not limited to geographic location, market demands, experience, training, and education. The benefits available for this position are dependent on hours worked and may include medical, dental, vision, 401(k) plan, pension plan, life insurance coverage, disability benefits, and PTO.

Corning Puts YOU First!

We are committed to supporting your health, financial, career development, and life goals as you grow professionally and personally to achieve your highest potential. All benefits begin as soon as you start your career at Corning.

• Our monetary peer-to-peer recognition program is tied to our Values and celebrates you and your colleagues’ contributions.
• Health and well-being benefits include medical, dental, vision, paid parental leave, mental health/substance use, fitness, and disease management programs.
• Financial benefits include a 401(k) savings plan with company matching contributions and a 100% company-paid pension benefit that grows steadily throughout your career.
• Companywide bonus and attractive short- and long-term compensation programs are available based on your role and responsibilities.
• Professional development programs help you grow and achieve your career goals.
  
  

We prohibit discrimination on the basis of race, color, gender, age, religion, national origin, sexual orientation, gender identity or expression, disability, veteran status or any other legally protected status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To request an accommodation, please contact us at accommodations@corning.com .