Associate Regulatory Affairs Director

Company: AstraZeneca GmbH
Location: Gaithersburg
Posted on: October 20, 2024

Job Description:

EMPLOYER: AstraZeneca Pharmaceuticals LPTITLE: Associate Regulatory Affairs DirectorLOCATION: Gaithersburg, MDHOURS: Full-Time; Mon-Fri (40 hours/week)DUTIES:

• Lead the end-to-end planning, coordination, and execution of assigned deliverables.
• Contribute to regulatory submission strategy, identifying submission risks and opportunities.
• Lead regulatory applications while managing procedures through approval.
• Provide regulatory expertise and guidance on procedural and documentation requirements to GRET, GRST, and cross-functional teams.
• Analyze regulatory procedures and special designations used during the development, authorizations, and extension of the product.
• Share best practices when handling various applications and procedures during interactions with health authorities.
• Lead and contribute to the planning, preparation (including authoring where relevant), and delivery of both simple and complex submissions throughout the product's life cycle.REQUIREMENTS:
• Must have a Bachelor's degree, or foreign equivalent, in Biology, Biotechnology or a related field.
• Five (5) years of global regulatory affairs experience within the pharmaceutical industry in the job offered, as a Regulatory Affairs Specialist, or in a related occupation.
• Experience must include:
• Leading submission strategy and execution of dossiers to global Regulatory Agencies.
• Reviewing and authoring of regulatory submission documents.
• Interpreting Health Authority procedures and requirements for pharmaceutical products.
• Identifying and mitigating risks to regulatory submission.
• Performing vaccine and/or biologics regulatory submissions.
• Working with first wave Marketing Applications and/or life cycle maintenance pharmaceutical submissions to multiple Regulatory Agencies, including FDA, EMA, and International markets.
• Supporting operational compliance, ensuring accurate completion of trackers and RIMS.
• Implementing CAPAs if required.
• Working with the Pharmaceutical Drug Development process.
• Performing project management of cross-functional regulatory delivery teams.Click Apply to submit your application. No calls please. EOE.
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Keywords: AstraZeneca GmbH, Wheaton-Glenmont , Associate Regulatory Affairs Director, Executive , Gaithersburg, Maryland