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AstraZeneca · 4 months ago

Regulatory Affairs Director, Global Regulatory Strategy

US - Gaithersburg - MD

Full-time

Onsite

Director/Executive

$186K/yr - $279K/yr

AstraZeneca is a global biopharmaceutical company seeking a Regulatory Affairs Director for Global Regulatory Strategy. The role involves providing strategic regulatory advice, ensuring compliance with product licenses, and collaborating across various teams to facilitate rapid submissions and approvals.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

Responsibilities

Provides effective lobbying and influencing on regulatory agencies and trade associations on product and legislative development issues and monitors changes in the regulatory environment in nominated region to support and advise relevant functions

Provides strategic regulatory advice support for product developments regional therapy area

Represents AZRA on relevant external Trade Association committees to ensure AZRA and/or AZ views on key issues are known

Ensures adequate risk assessments and mitigation plans are included in the regulatory strategy documents

Contribute effectively to Global Development programmes, providing expert advice and interpretive inputs on market legislation and requirements that impact on new and existing product registrations

Ensures effective collaboration across the global, regional and local Regulatory Affairs interface enabling rapid and effective submissions, approvals and other product maintenance activities

Participates in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project

Ensures all markets remain in compliance with product licences maintained and ensuring improvement plans are in place to close compliance gaps. Provide support and advice on training and development to ensure all regulatory personnel in markets have an appropriate knowledge of quality and compliance

Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration

Qualification

Regulatory drug developmentLeadership experienceProject managementRegulatory procedures knowledgeGlobal regulatory experienceStrategic influencingCollaborative relationshipsProblem solving

Required

Bachelor's Degree in Life Science or related discipline, advanced degree a plus

Significant experience of regulatory drug development, manufacture, commercialisation or equivalent

Proven successful leadership and project management experience

Broad background of experience of working in several groups in regulatory affairs or experience at a health authority

Knowledge of regulatory procedures and legislation for drug development, product registration, line extension and licence maintenance

Preferred

Significant Regulatory Experience across global projects and regions

Strong commercial awareness

Problem solving skills

Focus on delivery and results

Excellent strategic influencing and negotiation

Develops collaborative working relationships

Benefits

Short-term incentive bonus opportunity

Equity-based long-term incentive program (salaried roles)

Retirement contribution (hourly roles)

Commission payment eligibility (sales roles)

Qualified retirement program [401(k) plan]

Paid vacation and holidays

Paid leaves

Health benefits including medical, prescription drug, dental, and vision coverage

Company

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999