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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