Covance Regulatory Submissions Associate I in Mexico

Job Overview

Covance is currently hiring a Regulatory Submissions Associate for our location in Mexico, City!

Responsibilites/Duties:

  • Assist in the preparation of submissions filed to Regulatory Authorities (e.g.: INDs, CTAs, NDAs, NDSs, MAAs or CTDs).

  • Contribute to the preparation of submissions to Regulatory Authorities by reviewing/summarizing scientific/research documents.

  • Assist in the coordination, collection and organization of information required by Regulatory Authorities.

  • Interact with the Publishing group, Copy Center or equivalent as necessary for the production of submissions.

  • Maintain knowledge and awareness of regulations and guidelines pertaining to drugs and biologics.

  • Monitor compliance with regulatory requirements in relation to assigned projects.

Education/Qualifications

Recommended:

  • Bachelor’s Degree in Life Sciences or equivalent

Experience

Minimum Required:

  • Excellent communication skills, organization and planning skills and attention to detail

  • Up to 1 year regulatory affairs experience

Preferred:

  • Experience in the pharmaceutical industry

Job Number 2018-21863

Job Category Clinical Operations

Position Type Full-Time

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.