Regulatory Operations Specialist

OLIXIR New York; New York (NY); On-site; USD 75,000 - 110,000; Full time

Job summary

OLIXIR New York is seeking a Regulatory Operations Specialist to manage regulatory submissions for client brands, ensuring accuracy and efficiency while adhering to industry standards. You will handle day-to-day workload for 1-3 brands, coordinate with internal teams, and maintain trackers and submission portals (Veeva Vault, Aprimo).

A Bachelor's or Associate's degree and 1+ year in pharma advertising or a related regulated industry are preferred.

Qualifications

• Bachelor's or Associate's degree; 1+ year in pharmaceutical advertising or regulated industry.
• Experience with regulatory submissions and portals is preferred.
• Veeva PromoMats Certification and familiarity with Vault/Aprimo is a plus.
• Strong planning, problem-solving, and organizational skills.

Responsibilities

• Manage regulatory submissions for 1-3 client brands, ensuring accuracy and efficiency.
• Collaborate with agency team members and maintain trackers and process decks.
• Coordinate submission activities, including uploading documents and tracking status.
• Ensure compliance with regulatory requirements and update SOPs as needed.
• Communicate submission status, requirements, and challenges to the team.

Skills

Regulatory submissions

Planning

Organizational skills

Communication

Microsoft Office Suite

Teams

Education

Associate's degree

Bachelor's degree

Tools

Veeva PromoMats Certification

Veeva Vault

Aprimo

Job description

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.

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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to be updated