About this role
Agency:
Olixir
Job Function:
Production
Job Subfunction:
Production Operations
Job Description:
As a Senior Regulatory Operations Specialist, you'll oversee regulatory submissions for diverse brand portfolios, ensuring compliance with industry standards, agency protocols, and client requirements. You'll leverage exceptional planning, problem-solving, and communication skills to efficiently manage submissions and deadlines, utilizing expertise in FDA/OPDP regulations.
Manage multiple client brands across various business lines, prioritizing workload to meet deadlines and ensuring compliance with agency processes. Serve as subject matter expert on standard operating procedures for assigned brands, mentoring junior team members and contributing to internal best practices. Coordinate with cross-functional teams, communicating submission status, requirements and challenges, and maintaining accurate trackers and process documents. Oversee regulatory submissions, including uploading documents, annotating pieces, tracking status and addressing missing metadata or MLR comments. Ensure seamless execution of resubmissions, final submissions and validation, adhering to client-specific regulatory processes and agency administrative protocols.
Associate's or Bachelor's degree, with 3+ years of experience in pharmaceutical advertising or a regulated industry, and Veeva PromoMats Certification (a plus). Advanced knowledge of MLR processes, annotation/referencing, submission structures and client portals (Veeva Vault, Aprimo). Strong organizational, problem-solving and communication skills. Proficiency in Microsoft Office and Teams. Ability to manage multiple brands, prioritize tasks and meet deadlines in a fast-paced environment. Leadership skills, with proactive communication, critical thinking and collaboration.
$65,000-$80,000
To the extent permissible by local law, Omnicom’s policy requires employees to work in the office for a minimum of three days a week, unless additional in-office days are directed by their agency or manager.
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For US Job Seekers:
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