Associate Regulatory Affairs Director
AstraZeneca

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. Play a key role in contributing to regulatory submission strategy, identifying submission risks and opportunities, and leading 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. 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. 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 from either a global or regional perspective.

REQUIREMENTS: Must have a Bachelor's degree, or foreign equivalent, in Biology, Biotechnology or a related field, and 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. Must have Five (5) years of experience must include: Leading submission strategy and execution of dossiers to global Regulatory Agencies within the Pharmaceutical Industry; 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.

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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.