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.