The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables.
Compensation
The annual base salary for this position ranges from $135,182.40 - 202,773.60 USD Annual
Responsibilities
Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s).
Review documents and provide regulatory input (e.g., response documents, high level documents, study protocols, PSRs, etc).
Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
Own new business with Top 20 Pharma customers, running the full sales cycle from first conversation through pilot to signed contract.
Compensation
Competitive base salary and on-target earnings, plus meaningful equity.
Responsibilities
Own the full sales cycle, from prospecting through scoping, negotiation and close, and be accountable for quarterly and annual targets.
Develop account strategies with the founders, identifying high-potential accounts, key decision-makers and the highest-value use cases.
Open new accounts through targeted outbound, and build trust-based relationships with senior and C-level stakeholders across bioanalysis, CMC, clinical development, quality and IT.
Qualify opportunities and scope pilots with clear success criteria, making the case for ROI and working with delivery so we only commit to what we can deliver.
Maintain strong pipeline discipline and accurate forecasting.
The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables.
Compensation
The annual base salary for this position ranges from $135,182.40 - 202,773.60 USD Annual
Responsibilities
Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including Submission delivery strategy of all dossiers and all application types per market and/or region.
Review documents and provide regulatory input (e.g., response documents, high level documents, study protocols, PSRs, etc).
Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
Use and share best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.
The Regional Medical Lead (RML) for ICON Neuroscience is a critical leadership role working in a matrix environment with Medical and cross-functional teams that define Global strategies and support country affiliates in advancing the pipeline and enabling launch success.
Compensation
Princeton - NJ - US: $207,490 - $251,433
Responsibilities
Represent ICON and connect Global and Local
Lead Global & Local (G&L) strategic integration by representing market needs, translating global direction into actionable regional plans, and ensuring country insights meaningfully shape Global strategies
Partner closely with Global Medical Product Leads (MPLs) and global cross functional working groups translating Global objectives into a Regional perspective that supports the commercialization of scientifically differentiated assets
Proactively seek timely and quality inputs and feedback from Local teams to inform clinical programs and commercialization strategies and represent & advocate for Regional and Local needs within Global settings
Serve as the central liaison between Global Medical and Country Medical leadership and business leaders in the region ensuring aligned communication, coordinated execution, and timely escalation of needs, risks, and strategic priorities
Help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics.
Responsibilities
Forecasts submission/approval timelines and ensures they are adhered to.
Prepares ongoing submissions, amendments, required by central and local EC/IRB, as required by local rules.
Submits end of study notifications to ECs/IRBs and other local authorities in the specified country according to national timelines.
Performs/oversees essential document collection and review, ensuring that sponsor and investigator obligations are being met and comply with applicable local regulatory requirements and ICH/GCP guidelines.
Local Investigator Contract and budget negotiator (where applicable) produces site-specific contracts from country template.
Requirements
Undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional
Associate Regulatory Affairs DirectorNewAstraZeneca · Gaithersburg, US
Director of Business Development - PharmaNewAlchemi · New York, US