Manager Regulatory Affairs

Job Description

The Manager, Regulatory Affairs provides regulatory support for oncology products in early- and late-stage development. In this role, the Manager of Regulatory Affairs will support the regulatory lead on program related projects and be responsible for interacting with multiple functions to manage high quality regulatory submissions.

This role is responsible for the supporting regulatory submissions such as: investigational new drug applications (INDs), clinical trial applications (CTAs) and components of marketing applications as well as post-approval submissions and life-cycle maintenance activities.

Key Responsibilities:

Provide input to global regulatory submission strategy, preparing regulatory submission documents, and reviewing regulatory submissions for completeness and quality in global accordance with regulatory agency requirements, standards, and corporate practices

Previous experience with compilation and filing of INDs, IND amendments, NDA, NDA supplements and CTAs.

Represent the regulatory affairs function on project teams to provide regulatory support and advice

Interact with corporate partners and contracted vendors regarding various regulatory matters

Provide support for regulatory interactions, including meetings and teleconferences with global health authorities

Show good judgment to determine when to escalate problems to his/her superior

Draft and/or modify applicable SOPs and/or other written practices relating to the regulatory affairs function