Compliance Intern involved in monitoring medicine inventory and supporting clinic roles. Responsibilities include documentation, compliance checks, and data organization.
About the role
- Director of Promotional Regulatory Affairs at AstraZeneca overseeing FDA compliance and regulatory strategy development. Collaborating with cross-functional teams to ensure promotional materials meet standards.
Responsibilities
- Drive efficient and effective regulatory review and risk assessment for promotional materials across HCP, Consumer, and Managed Markets segments and all media types.
- Lead innovative regulatory strategy development and implementation, including risk identification and contingency planning.
- Collaborate with MLR planners, reviewers, and asset owners on asset prioritization and consultation; advise business leadership on Brand strategy.
- Provide input to global teams on how proposed TPP/TPC/TPL documents, labeling, studies, and corporate initiatives may affect US promotion.
- Serve as primary liaison with OPDP/APLB for assigned brands.
- Evaluate brand regulatory training needs and develop and deliver training in partnership.
- Follow and enhance established processes and guidelines; develop PRA guidance documents and job aids to increase clarity, speed, and quality in review and approval.
- Monitor regulatory agency activities, guidance documents, and emerging trends; distill and share implications with PRA and cross-functional partners.
- Shape PRA vision, practices, and operational plans; contribute to team objectives and priorities with a focus on measurable outcomes and continuous improvement.
- Act as a role model for performance and ways of working; manage, develop, and mentor less experienced staff.
- Represent the company as a subject matter expert internally and externally.
Requirements
- Bachelor’s degree in science
- 3+ years’ experience in promotional regulatory affairs, FDA (OPDP/APLB), or other equivalent experience in advertising and promotion review
- 5+ years total experience in pharmaceutical/biotech industry, FDA, or equivalent experience
- Strong knowledge of FDA promotional regulations and ability to apply such knowledge in review of diverse promotional materials and audiences
- Knowledge of the drug development and labeling processes
- Advanced degree in life sciences, pharmacy, law, or a related discipline is a plus
- 10 or more years of experience in US promotional regulatory affairs within biopharma, including direct OPDP/APLB interactions and resolution of advisory or enforcement matters is a plus
- Experience leading or co-chairing MLR processes and operating within digital review systems such as AZAP or comparable platforms is a plus
- Launch-to-lifecycle leadership across HCP and consumer promotions, managed markets materials, and omnichannel/digital campaigns is a plus
- Proven ability to design and deliver effective regulatory training for commercial and medical stakeholders is a plus
- Demonstrated influence at senior levels to shape departmental practices and operational plans is a plus
- People leadership experience with a track record of coaching and building high-performing teams is a plus.
Benefits
- Health insurance
- Retirement plans
- Flexible work arrangements
- Professional development
- Bonuses
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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