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CMC Product Quality Compliance Specialist

Employer
Regeneron Pharmaceuticals, Inc.
Location
Troy, New York
Start date
Sep 19, 2022

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Discipline
Clinical, Clinical Medicine, Science/R&D, CMC
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work
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Job Details

The Chemistry, Manufacturing, and Controls (CMC) Product Quality Compliance Specialist is the Quality representative for product and distribution compliance of Regeneron’s commercial programs including support with the product quality reviews (PQR). This role supports the development, coordination and ownership of the quality and compliance elements of the life cycle strategy, including ownership of the global regulatory change management implementation plan, end-to-end optimization efforts and coordinating product management activities. This position works collaboratively with CMC team members, alliance partners, collaborators and CMOs to ensure continuity of supply, consistency within and across programs, supply strategy alignment across functions, and compliance process efficiency.

As a CMC Product Quality Compliance Specialist, a typical day might include the following:

  • Coordinates the global change management implementation plan
  • Supports the evaluation of impact of proposed process changes, deviations and CAPAs on the end-to-end supply chain.
  • Leads all aspects of the coordination and generation of the annual PQRs and yearly biologic product reports (YBPR).
  • Assesses quality-related information to detect trends and works with subject matter authorities to resolve need for actions required in response to those trends
  • Ensures drug supply distribution compliance with all aspects of global regulatory filings to ensure stable supply positioning.
  • Interacts with global regulatory authorities in support of the CMC activities during Agency inspections.
  • Collaborates cross-functionally to support regulatory release process and inventory review.
  • Performs relationship management with other areas of Regulatory, Quality, Manufacturing, and Supply organizations to support product distribution.
  • Develops procedures and systems for enhanced tracking of change controls and global regulatory submissions/approvals.
  • Support launch readiness and distribution compliance through ensuring appropriate GMP source documentation is in place to support regulatory activities and launch material is aligned with the applicable regulatory dossiers.
  • Responsible for providing writing and strategy support in communications to regulatory agencies including product deviation reports (BPDR, QDR, DPR, etc.), clinical notice of events and agency inspection responses in collaboration with CMC RA, QA, and SMEs as applicable.
  • Facilitates the commercial and registration requests (CARRs) process in collaboration with CMC PM, CMC RA, IMT and SMEs as applicable.

This role may be for you if you have:

  • Experience preferably pharmaceutical or medical device, including some supervisory and/or leadership experience.
  • Ability to perform independent work requiring attention to detail and accuracy and a consistent record of shifting thought processes quickly from one task to another
  • Record of establishing and maintaining effective working relationships with managers and employees as well as influencing individuals of various levels to gain understanding and/or acceptance of an idea, policy, procedure, or plan
  • Possess excellent interpersonal, written and oral communication skills with the ability to use active listening skills to understand concerns or reasoning in order to be responsive, gain trust and build strategic relationships

To be considered for this role you must hold a BS/BA degree in Chemistry, Biology and

  • Associate Specialist: 0-2 years of relevant experience
  • Specialist: Requires 2+ years of relevant experience
  • Senior Specialist: Requires 5+ years of relevant experience
  • Leveling is decided on during an interview process; equivalent combination of education and experience may be considered

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

#REGNQA #LI-Hybrid

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Find Us
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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