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Regulatory Affairs Specialist, Biologics

**Date:** Apr 4, 2025

**Location:** Tewksbury, MA, US, 01876

**Company:** Corning

Requisition Number: 67375

The company built on breakthroughs. ​ 

Join us.​ 

Corning is one of the world’s leading innovators in glass, ceramic, and materials science. From the depths of the ocean to the farthest reaches of space, our technologies push the boundaries of what’s possible.  ​

How do we do this? With our people. They break through limitations and expectations – not once in a career, but every day. They help move our company, and the world, forward. ​

• At Corning, there are endless possibilities for making an impact. You can help connect the unconnected, drive the future of automobiles, transform at-home entertainment, and ensure the delivery of lifesaving medicines. And so much more.​

• Come break through with us.

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.

​

A job that shapes a life. 

Corning offers you the total package. 

Your well-being is our priority. Our compensation and benefits package supports your health and wellness, financial, and career from day one

+  As part of our commitment to your financial well-being, we provide a 100% company-paid pension benefit that grows throughout your career. We also offer a 401(k) savings plan with company matching contributions.

+ Our health and well-being benefits include medical, dental, vision, paid parental leave, family building support, fitness, company-paid life insurance, disability, and disease management programs.

+ Company-wide bonuses and long-term incentives, align with key business results and ensure you are rewarded when the company performs well – when Corning wins, we all win.

+ Getting paid for our work is important but feeling appreciated and recognized for those contributions motivates us much more. That’s why Corning offers a peer-to-peer recognition program to celebrate success by recognizing colleagues who demonstrate above-and-beyond behaviors.

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.

**Nearest Major Market:** Boston