Manager, Regional Regulatory Lead – LCM

CSL

Regulatory Lead managing interactions with health authorities for product submissions. Ensuring regulatory strategy alignment and successful outcomes with GRAST teams at CSL Behring.

Posted 7/23/2026full-timeKing of Prussia • Massachusetts, Pennsylvania • 🇺🇸 United StatesSenior💰 $129,000 - $153,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive regulatory experience in the biotech or pharmaceutical industry, with a strong focus on product development and approval processes in key regions such as the EU and US. Proven ability to engage with health authorities and maintain compliance through effective communication and collaboration within a complex, matrix environment.

Highest-signal resume keywords

Regulatory Affairs ExperienceHealth Authority InteractionPharmaceutical Product DevelopmentStrategic ThinkingCommunication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionProduct DevelopmentRegulatory RequirementsBiotech Industry KnowledgePharmaceutical Industry KnowledgeVeeva System ManagementClinical Medicine KnowledgePharmacology KnowledgeBiology KnowledgeChemistry Knowledge

Soft Skills

Verbal CommunicationWritten CommunicationRelationship BuildingStrategic AssessmentInnovative Problem Solving

Certifications & Qualifications

Bachelor’s Degree in PharmacyBachelor’s Degree in BiologyBachelor’s Degree in ChemistryBachelor’s Degree in PharmacologyBachelor’s Degree in Clinical MedicineAdvanced Degree (MS, PhD, MD, DVM, or MBA)

Industry Keywords

Regulatory StrategyGlobal Regulatory AffairsFDAEMAComplex EnvironmentMatrix EnvironmentDevelopmental ProductsPatient-Centric FocusRegulatory DeliverablesCommercial Operations

About the role

Key responsibilities & impact

Regulatory leaders who leverage regional regulatory experience to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision/strategies for assigned product/s with a patient-centric focus.
Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) and other regional, labeling and CMC GRAST members.
Ensure bi-directional communication with stationed region commercial operations and GRA.
Engage with health authority (HA) in stationed country (FDA or EMA).
Contribute to product health authority interaction with support GRL or Regulatory TA Head.
Partner with GRAST members to achieve regulatory deliverables.
Update and maintain applicable regulatory systems (e.g., Veeva) to ensure tracking and compliance deliverables.

Requirements

What you’ll need

Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, Clinical Medicine, or related life science field.
Advanced degree in a related field (MS, PhD, or MD, DVM) or MBA is preferred
Minimum of 5+ years of regulatory/submission experience in the biotech or pharmaceutical industry
3+ years of experience working on developmental products
Knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in one or more key regions (EU, US, Japan)
Experience working in Regulatory Affairs with agency interaction responsibility with at least one health authority is preferred.
Relevant experience working in a complex and matrix environment.
Ideal candidates will have clinical or device foundation
Demonstrated ability to think strategically, assesses prudent risks and develop bold, agile, innovative approaches to complex challenges
Proven effective verbal and written communication skills and ability to successfully work across all levels of the organization
Foster productive, working relationships within CSL (e.g., R&D and Commercial).

Benefits

Comp & perks

Health insurance
Retirement plans
Paid time off
Flexible work arrangements
Professional development opportunities