Senior Manager / Director, Regulatory Affairs

X4 Life Sciences are working with a state-of-the-art, fast-growing generics manufacturer based out of Bucks County, PA who are looking to bring on board a Senior Manager, Regulatory Affairs OR a Director, Regulatory Affairs as soon as possible.

This role is responsible for compiling technical files (ANDAs, NDAs, DMFs) for their exciting drug pipeline, overseeing all activity with external manufacturing and research partners, and leading a small team of RA Specialists.

This is a fully on-site position, but commuting to their new, ultra-modern site will be more than worth it! A relocation assistance package is on offer if needed.

They're looking to hire as soon as possible - please see a summary of the position below:

Position:

• Title: Senior Manager, Regulatory Affairs OR Director, Regulatory Affairs
• $140k-$220k + benefits + bonus
• Location: Bucks County, PA (on-site)
• Start date: ASAP

Areas of experience needed:

• Knowledge & Experience of compiling CMC sections of ANDAs & NDAs (eCTD), reviewing DMFs
• 10+ years' RA experience within pharmaceutical manufacturing
• Working knowledge of FDA regulations (e.g., 21 CFR 314.50 and 314.94 and 21 CFR 201 and 208) and applicable FDA guidance
• Experience working with & overseeing external resources (e.g., CROs, CMOs) and a team of direct reports

Could this opportunity be of interest to you? Apply now!

Candidates requiring visa sponsorship will be considered!

If you know of someone in your network who could be a good fit for this role, don't hesitate to let me know - we offer a cash reward for successful referrals!