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Regulatory Affairs I
Ref No.: 18-07853
Location: Santa Ana, California
Start Date: 06/28/2018
The Regulatory Affairs Associate is responsible for routine regulatory support and for providing guidance to support timely objectives and maintenance of assigned programs. Responsible for supporting the general management of the advertising and promotion copy clearance process for promotional assets across the organization. This will be accomplished by partnering with our internal and external stakeholders and working within our internal digital asset management tool to traffic & monitor projects through their workflow cycles. He/she must be knowledgeable of applicable global regulations, guidance documents and regulatory pathways.

DUTIES: Develops and communicates regulatory support with the goal of achieving timelines and milestones. Conduct screening of copy clearance submissions for completeness and compliance with processes and standards. Track progress of projects in the copy clearance workflow system and follow-up with submitters and reviewers to ensure timelines are met for their respective tasks. Review final assets in a timely manner to ensure required changes were made. Respond to routine inquiries regarding copy clearance processes and system support for the Global, North America, and regional copy clearance processes. Coordinates meetings, solicits agenda topics from team members for regulatory team meetings as well as produces meeting summaries/minutes. Collaborates with pertinent team members to ensure that deliverables are available in a timely manner. Manage expiring assets to ensure compliance with procedures. Generate copy clearance metrics on a routine basis. Maintains a working knowledge of current advertising and promotional global regulatory standards, requirements, regulations and guidance's. Assists with ensuring company compliance with all applicable global regulatory guidance, regulations, and laws. Applies knowledge of regulatory requirements to support review of advertising and promotion claims. Provides guidance and direction to key stakeholders under the supervision of senior regulatory staff. Develops and maintains good working relationships with team members. Performs all other duties as assigned or as business needs require. Performs additional task/projects as they arise.

EXPERIENCE/EDUCATION: A minimum of 2 years of industry/related experience OR a PharmD and 1 year of industry/related experience is required. A minimum of 1 year of Regulatory Affairs experience and 3 years in medical regulated industry experience is preferred. A minimum of a Bachelor's degree is required. Some project management at running meetings/taking meetings minutes/building agendas. Strong interpersonal, collaborative skills.