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, Arlington , Associate Regulatory Affairs Director, Executive , Gaithersburg, Virginia
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