Regulatory Compliance Specialist overseeing compliance for Arc'teryx raw materials and goods. Collaborating across teams to uphold regulatory frameworks and ensure consumer safety with legal standards in focus.
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
Head of Compliance at Compass managing enterprise risk, information security, and multi - jurisdictional regulatory compliance. Building compliance frameworks in an exciting high - growth SaaS environment.
Regional Regulatory Lead overseeing EUCAN regulatory strategy for pharmaceutical projects and products. Planning submissions, coordinating meetings, and collaborating with regulatory authorities.
Manager Regulatory Affair at Capgemini Engineering coordinating activities for the US market. Preparing submissions to the FDA and collaborating with internal teams for regulatory compliance.
Engineer IT Compliance responsible for compliance activities in regulated IT systems. Building partnerships with IT functions and ensuring regulatory alignment in pharmaceutical industry.
Regulatory Affairs Associate for managing new drug registrations and preparing documentation in the India Market. Collaborating with stakeholders and supporting compliance in bulk drug registration.
Senior Tech Compliance Analyst at Syneos Health responsible for global Technology Disaster Recovery efforts, collaborating with various teams and service providers.
BL
Chief Nuclear Officer serving as the nuclear safety authority for BaRupOn's SMR/MMR programs. Establishing safety frameworks and ensuring regulatory compliance within the organization.
International Trade Compliance Manager overseeing compliance with international trade regulations at Northrop Grumman. Leading a team and managing compliance initiatives across multiple locations in the US.
Compliance Manager leading Autodesk's Enterprise Compliance program. Ensuring compliance with SOX, PCI regulations and overseeing security controls across teams.