Regulatory Operations Specialist

Agency:

Olixir

Job Function:

Production

Job Subfunction:

Production Operations

Job Description:

As the Regulatory Operations Specialist, you will manage regulatory submissions for client brands to ensure accuracy and efficiency while following industry standards. Your role requires strong organizational and communication skills, with the ability to work collaboratively in a fast-paced environment.Manage day-to-day workload for 1-3 client brands, prioritizing tasks to meet deadlines and staying up-to-date on standard operating procedures.
Communicate effectively with agency team members, providing updates on submission status, requirements, and challenges.
Maintain accurate trackers and process decks, ensuring compliance with agency administrative processes and ways of working.
Coordinate submission activities, including uploading documents, tracking status, and downloading MLR comments.
Collaborate with internal teams, sharing information and best practices to ensure seamless submission processes.
Ensure compliance with regulatory requirements, uploading relevant supporting documents and linking tactics to component assets as needed.Associate's or Bachelor's degree preferred, with 1+ year of experience in pharmaceutical advertising or a related regulated industry.
Veeva PromoMats Certification and experience with submission portals (e.g., Veeva Vault, Aprimo) preferred.
Strong planning, problem-solving, and organizational skills, with proficiency in Microsoft Office Suite and Teams.
Excellent written and verbal communication skills, with the ability to work effectively in a fast-paced environment.
Understanding of MLR submission processes, fact checks, and reference annotations, with ability to navigate submission portals.
Ability to work proactively and independently, with strong time management skills and a team-oriented approach.

to be updated

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