Assoc CMC Product Quality Compliance Specialist

Regeneron; United States; On-site; USD 62,000 - 92,000; Full time

Job summary

Regeneron is seeking a Quality and Regulatory representative to lead product quality reviews and ensure compliance across the life cycle. The role owns global change management, PQRs and regulatory submissions in collaboration with CMC, QA, and manufacturing teams.

You’ll work with alliance partners and CMOs to maintain supply continuity, drive process improvements, and support inspection readiness and regulatory communications. On-site requirements apply in many locations.

Qualifications

• Assoc Specialist requires BS/BA in Chemistry, Biology, or related field with relevant experience or equivalent combination of education and experience.
• Specialist requires BS/BA in Chemistry, Biology, or related field with 2+ years of relevant experience and supervisory/leadership experience or equivalent.
• Sr Specialist requires BS/BA in Chemistry, Biology, or related field with 5+ years of relevant experience and supervisory/leadership experience or equivalent.

Responsibilities

• Oversees 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.
• Oversees 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 experts to determine the 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.
• Executes 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, PDR, 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.

Education

Assoc Specialist: BS/BA in Chemistry, Biology, or related field, with relevant experience or equivalent combination of education and experience

Specialist: BS/BA in Chemistry, Biology, or related field, with 2+ years of relevant experience and supervisory/leadership experience or equivalent

Sr Specialist: BS/BA in Chemistry, Biology, or related field, with 5+ years of relevant experience and supervisory/leadership experience or equivalent

Job description

Summary: Responsible for being a 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 overseeing product

management activities. 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.

Key Responsibilities

• Oversees 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.
• Oversees 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 experts to determine the 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.
• Executes 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, PDR, 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.

Education and Experience:

• Assoc Specialist: Requires BS/BA in Chemistry, Biology, or related field, with relevant experience or equivalent combination of education and experience, preferably pharmaceutical or medical device, including some supervisory and/or leadership experience.
• Specialist: Requires BS/BA in Chemistry, Biology, or related field, with 2+ years of relevant experience in pharmaceutical or medical device, including some supervisory and/or leadership experience or equivalent combination of education and experience.
• Sr Specialist: Requires BS/BA in Chemistry, Biology, or related field, with 5+ years of relevant experience in pharmaceutical or medical device, including some supervisory and/or leadership experience or equivalent combination of education and experience.

We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$62,355.00 - $92,400.00