Senior Regulatory Affairs Associate - Generalist

Job overview

The Senior Regulatory Affairs Associate - Generalist is an onsite role based in Juneau, Alaska, with Parexel. This position provides end-to-end regulatory affairs support for a strategic pharmaceutical partnership, working closely with internal teams and external alliance stakeholders. Compensation is not specified. The overarching purpose of this role is to ensure regulatory excellence across clinical, submission, and post-approval activities. The Associate will manage regulatory planning, documentation, and submission execution, ensuring compliance with global regulatory requirements while serving as a key interface within the partnership.

What you'll do

• Maintain U.S.
• regulatory archive logs, including recording new submissions and archiving regulatory authority correspondence.
• Maintain and update trackers for Form FDA 1572 waiver requests and other clinical regulatory documentation.
• Draft administrative components of regulatory submissions, including FDA forms and cover letters.
• Prepare presentation materials and slide decks for Global Regulatory Team (GRT) meetings.
• Contribute to the drafting, review, and preparation of regulatory submissions across development phases.

What we're looking for

Skills & competencies

full-time

day shift

onsite

juneau ak

parexel

regulatory affairs

pharmaceutical

clinical trials

compliance

submission

fda

Work arrangement

• Weekend coverage required

Benefits & perks

• Not specified.

Why this role

3+ years of related regulatory affairs experience in an industry-related environment; Bachelor's degree in a Scientific or Technical Discipline required.

About the employer

Parexel is hiring for this role. Industry: Custom Computer Programming Services. Sector: 54.