Regulatory Submissions Specialist — Pharma Ops

OLIXIR New York; New York (NY); Híbrido; USD 70.000 - 110.000; Jornada completa

Descripción de la vacante

OLIXIR New York is seeking a Regulatory Operations Specialist to manage regulatory submissions for client brands, ensuring accuracy and efficiency. The role requires strong organizational and communication skills and the ability to work collaboratively in a fast-paced environment.

You will handle 1–3 client brands, prioritize tasks to meet deadlines, and stay up-to-date on standard operating procedures while coordinating with internal teams and stakeholders.

Formación

• Associate's or Bachelor's degree preferred.
• 1+ year in pharmaceutical advertising or related regulated industry preferred.
• Veeva PromoMats Certification preferred and experience with submission portals (Veeva Vault, Aprimo) preferred.
• Understanding of MLR submission processes, fact checks and reference annotations.

Responsabilidades

• Manage regulatory submissions for client brands to ensure accuracy and efficiency.
• Collaborate with agency team members and provide updates on submission status, requirements and challenges.
• Maintain trackers and process decks, ensuring compliance with agency administrative processes.

Conocimientos

Planning

Problem solving

Organizational skills

Communication

MS Office

Teams

Educación

Associate's or Bachelor's degree

Herramientas

Veeva PromoMats

Veeva Vault

Aprimo

Descripción del empleo

OLIXIR New York is seeking a Regulatory Operations Specialist to manage regulatory submissions for client brands, ensuring accuracy and efficiency. The role requires strong organizational and communication skills and the ability to work collaboratively in a fast-paced environment.

You will handle 1–3 client brands, prioritize tasks to meet deadlines, and stay up-to-date on standard operating procedures while coordinating with internal teams and stakeholders.