Senior Regulatory Affairs Associate / Consultant- Non/Clinical Writing

AMAZING HOME-BASED OPPORTUNITY TO GROW PROFESSIONALLY! THIS ROLE OFFERS UNPARALLED CROSS FUNCTIONAL REGULATORY AFFAIRS, THERAPEUTIC AREA, AND FDA EXPOSURE!

If you love writing, have a passion for Regulatory Affairs, and are looking for an opportunity that will allow you to continue to have the flexibility of working from home while gaining tremendous professional experience, then Parexel's Regulatory Consulting team has an amazing opportunity for you!

Our Regulatory Consulting Team is expanding, and we are seeking a Senior Regulatory Affairs Associate or a Regulatory Affairs Consultant to join our team of Regulatory experts and assist our clients with pre-market and post -market submissions! This is a great opportunity to continue to expand your Regulatory Affairs experience as you work with and are mentored by some of the Industry's leading experts. You will gain great exposure as you prepare for client and FDA meetings, write various sections of Applications, interact with Industry Thought Leaders and Subject Matter Experts, etc.

In this role, you will:

•Serve in the capacity of Regulatory clinical technical writer and as US Agent and as a Regulatory Generalist

•Prepare regulatory submissions to FDA across a diverse portfolio of product types (small molecule, biologics, combinations), development phases, and scientific disciplines (nonclinical, clinical, general regulatory and/or device).

•Support multi-functional projects as project manager and collaborate with technical leads and clients to perform the work

•Review documents to provide quality assurance for both pre- and post-approval regulatory document submissions.

•Produce first-time quality work to meet expectations of both project lead and clients.

•Foster a strong network of colleagues through continued interactions during project engagement.

Qualifications1) PhD with 3+ yrs industry-related or academic focused regulatory affairs experience OR MS/BS with 5+ yrs experience.

2) demonstrated technical writing experience (including some clinical) regulatory documents for FDA submissions (i.e. meeting materials and IND/NDA/ or BLA documents)

3) project management and consultant experience necessary

4) US Agent/liaison to health authorities is highly valued

5) excellent interpersonal and intercultural communication skills, both written and verbal required

This role may require <30% domestic and/or international travel in the future

EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.