Pharma Regulatory Submissions Specialist

OLIXIR New York; New York (NY); Presencial; USD 75 000 - 110 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Regulatory submissions

Planning

Organizational skills

Communication

Microsoft Office Suite

Teams

Formação académica

Associate's degree

Bachelor's degree

Ferramentas

Veeva PromoMats Certification

Veeva Vault

Aprimo

Descrição da oferta de emprego

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.