Senior Specialist - Multiple Teams
About the job
- A bachelor's degree in life sciences, pharmacy, medicine, nursing, public health, epidemiology, regulatory affairs, or a related field, or equivalent experience is required.
- Four or more years of experience in biologics CMC regulatory affairs, with a focus on IMPD, IND, BLA, and MAA writing, is required.
- Ability to deliver customer or internal projects and processes in daily work, prioritize parallel tasks, escalate issues appropriately, and propose suitable countermeasures.
- Ability to analyze and solve problems and propose solutions for tasks or projects, with attention to detail and a high service orientation.
- Ability to work in a structured, systematic, and independent manner within established procedures, determining priorities with little supervision.
- Ability to train and support junior or new colleagues in daily activities and lead small projects with clearly defined scope.
- Ability to manage internal and external client relationships at operational and day-to-day working levels, as well as at the client's team-lead level.
- Good written and verbal communication skills, including the ability to communicate issues and propose solutions, and a confident professional presence.
- Business-fluent English is required.
- Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead.
- Participate in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products, including applications, renewals, and variations, as well as medical devices, with emphasis on CMC aspects.
- Support the preparation, review, and compilation of biologics CMC documents within regulatory affairs projects.
- Communicate with clients and Health Authorities in close cooperation with the respective lead.
- Support the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead.
- Provide general guidance and consultancy to colleagues and clients regarding CMC services.
- Develop and maintain personal regulatory knowledge, apply it to client projects, and actively share it with colleagues as part of regulatory intelligence.
- Support regulatory strategy implementation and optimization.
- Comply with and support the maintenance of internal procedures.
- Provide operational insights for practice-area-led commercial, marketing, and business development activities, including proposal input, in close cooperation with the respective lead.
- Support the respective lead in delivering to budget through accurate and timely reporting, and provide project insights to address invoicing queries.
- In agreement with Practice Area Management, provide on-site regulatory support to GCS clients.
- Take on other reasonable tasks corresponding with the employee's abilities upon agreement with the Line Manager, Practice Area Lead, or Head of Regulatory Affairs.
- Certification in pharmacovigilance or drug safety is preferred.
- Certification in regulatory affairs or clinical safety is preferred.
- Certification in quality management or auditing is preferred.
About the company
Cencora buys and distributes medicines for pharmacies, hospitals and physician practices, while helping drug manufacturers bring treatments to patients. Its businesses combine wholesale supply networks with specialty distribution for complex therapies and services that support prescribing and patient access. Customers order medicines through its distribution systems, and its teams manage sourcing, storage and delivery alongside pharmacy operations and manufacturer support. It earns revenue from pharmaceutical sales and fees for logistics and healthcare services. The parent company was formed in 2001 through the merger that created AmerisourceBergen, adopted the Cencora name in 2023, and is headquartered in Conshohocken, Pennsylvania.
Company Size
10,001+
Company Stage
IPO
Headquarters
Conshohocken, Pennsylvania
Founded
2001
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Simplify's Take
What believers are saying
- Pharmacy contracts deepen customer ties: Cencora negotiates insurer agreements and handles administrative work through its managed-care networks.
- Eligible US staff gain retirement support: Cencora counts student-loan payments toward its employer match, up to 4% of pay.
- Drug demand expands sales: Cencora reported 5.1% quarterly revenue growth in August 2026, led by higher US volumes.
What critics are saying
- Customer dependence concentrates risk: Walgreens and Boots supplied 25% of Cencora's fiscal 2025 revenue, reported in November 2025.
- Legal liabilities tie up cash: Cencora's November 2025 filing recorded $4.3 billion in opioid settlements, payable over 13 years.
- Warehouse work is physical: Cencora's day-shift associate listing requires repeated lifting up to 50 pounds and overtime availability.
What makes Cencora unique
- Independent pharmacies get a shared brand: Cencora's Good Neighbor Pharmacy franchise supports their merchandising and store identity.
- Specialty shipments use reusable packaging: Cencora's World Courier Cocoon containers combine passive temperature control with live location monitoring.
- Medicines arrive ready for bedside checks: Cencora's American Health Packaging sells barcoded unit doses that support hospital scanning.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
Paid Parental Leave
Adoption Assistance
Infertility Coverage
Family Planning Benefits
Behavioral Health Solutions
Professional Development Budget
Training Programs
Company News
Cencora has launched Cell and Gene Therapy Enablement through its Accelerate Pharmacy Solutions division to help health systems develop and expand cell and gene therapy programmes. The service provides support across financial planning, operational readiness, and scalable growth to reduce care barriers and improve patient access to advanced therapies. More than 35 cell and gene therapies have received FDA approval, with over 1,700 clinical trials underway globally. However, only 4% of health system pharmacy leaders report being fully prepared to integrate these treatments, highlighting infrastructure gaps. The offering includes market assessments, readiness evaluations, governance design, and workflow planning. Cencora, ranked number 10 on the Fortune 500 with over $300 billion in annual revenue, already provides specialty pharmaceutical services across the therapy lifecycle.
Cencora reported second-quarter revenue of $84.75 billion, slightly above analyst estimates of $84.43 billion, representing 5.1% year-on-year growth. Adjusted earnings per share came in at $4.48, beating consensus estimates of $4.35 by 3%. Management attributed the performance to strength in specialty pharmaceuticals, particularly through Management Services Organisations like OneOncology and RCA. CEO Robert Mauch highlighted the company's positioning in specialty care, stating, "Our specialty platform supports growth across the healthcare ecosystem." The company raised its full-year adjusted EPS guidance to $17.85 at the midpoint. Operating margin held steady at 1.3%, matching the same quarter last year. During the earnings call, analysts questioned management about biosimilar opportunities, specialty logistics competition, and potential policy risks from proposed ASP rule changes.
Cencora reported strong third-quarter results for fiscal year 2026, driven by execution across its business units and investments in its specialty positioning. The pharmaceutical distributor achieved double-digit adjusted operating income growth and 12% earnings per share growth in the quarter. The company conducted $1 billion in opportunistic share repurchases during the period. Based on its performance and confidence in continued execution, Cencora raised its fiscal 2026 EPS guidance. President and CEO Robert Mauch credited the results to the company's team members and their commitment to providing solutions for customers. He highlighted the strength of Cencora's portfolio and its pharmaceutical-centric strategy as the company approaches the end of its fiscal year. The earnings call was held on 5 August 2026, with senior leadership including Mauch and CFO Eva Boratto participating.
Cencora and its subsidiary Innomar Strategies have amended their credit agreement, increasing their multi-currency revolving credit facility from $5.5 billion to $7.0 billion. The facility's maturity date has been extended to July 2031. Interest rates on borrowings range from 69.5 to 110 basis points over various term rates, depending on Cencora's public debt ratings. The agreement includes covenants such as a maximum financial leverage ratio. Separately, on 31 July 2026, Cencora amended its receivables securitisation facility, reducing it from $1.5 billion to $1.0 billion whilst increasing the accordion feature from $500 million to $1.0 billion. This gives the company the option to expand commitments by up to $1.0 billion, subject to bank approval.
Wall Street analysts expect Cencora to report quarterly earnings of $4.37 per share, marking a 9.3% year-over-year increase. Revenues are projected to reach $84.89 billion, up 5.2% from the same quarter last year. Over the past 30 days, the consensus earnings per share estimate has been revised upward by 1.3%. Analysts forecast revenue from Total US Healthcare Solutions at $75 billion, representing 2.9% year-over-year growth. International Healthcare Solutions revenue is expected to remain flat at $7.79 billion. Operating income projections show US Healthcare Solutions at $940.87 million and International Healthcare Solutions at $158.45 million. Cencora shares have risen 5.3% over the past month and hold a Zacks Rank of 2, indicating expected outperformance versus the broader market.