EMPLOYER: AstraZeneca Pharmaceuticals LP
TITLE: Associate Regulatory Affairs Director
LOCATION: Gaithersburg, MD
HOURS: 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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