NewBrunswickRecruiter Since 2001
the smart solution for New Brunswick jobs

Senior Director/ Executive Director Regulatory Affairs CMC

Company: Hamlyn Williams
Location: New Brunswick
Posted on: February 21, 2021

Job Description:

A global Pharmaceutical organization is looking to hire a Sr. Director or Executive Director, Regulatory Affairs CMC to join the New Jersey Office's Regulatory Affairs function. The role will report to the VP Regulatory Affairs and will have director reports.Key Responsibilities* Responsible for the RA CMC strategic leadership to support a wide variety of therapeutic areas and dosage forms both within small molecule and biologics indications* Responsible for direct reports, leading, mentoring and developing a team of junior to mid-level regulatory CMC professionals* Manage and implement submissions of CMC related applications with a focus on the US and EU/EMEA region* Ensure that CMC sections (including IMPDs/INDs, MAAs or BLAs) are complete* Collaborate effectively with Regulatory Strategy Leads, coordinate negotiations on CMC topics--with regulatory agencies to resolve CMC issues* Effectively communicate regulatory CMC strategies to the VP Regulatory Affairs and other cross-functional teams* Assesses the impact of new regulations, guidances or enforcements and advise the Regulatory Group on requirements to maintain compliance with regulatory operations activities.Minimum Qualifications* M.S. degree in biochemistry, chemistry, biology, Ph.D. is desireable* 10+ years of relevant biopharmaceutical industry experience, with 8+ years experience in CMC-focused Regulatory Affairs with at least 5+ years of experience in biologics.Apply here or email r.burton@hamlynwilliams.com if you are interested in working with a--leader in the biopharma space.

Keywords: Hamlyn Williams, New Brunswick , Senior Director/ Executive Director Regulatory Affairs CMC, Executive , New Brunswick, New Jersey

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Assistant Salon Manager - Levittown Shopping Center
Description: Assistant Salon ManagerGot shears and a winning attitude Have a yearning to earn and a desire to support other stylists Then let's talk Maybe you're a stylist who wants more responsibility,
Company: Great Clips
Location: Levittown
Posted on: 03/5/2021

Retail Management - NJ North/Rockaway and Surrounding Area
Description: Store Manager - directly influences the performance of everyone who interacts with guests and supports a solution selling environment. The Store Leader is responsible for fostering a selling culture that (more...)
Company: Gamestop, Inc.
Location: West Orange
Posted on: 03/5/2021

Project Manager with Data migration exp
Description: Leads one or multiple projects and spearheads scope finalization, estimation, design, development, implementation and all phases of the project. Experience with project planning tools like MS projects (more...)
Company: Larsen & Toubro Infotech Ltd (LTI)
Location: Hoboken
Posted on: 03/5/2021


Project Manager II
Description: Job Summary The Project Manager - Construction is responsible for defining project scope and objectives, coordinating activities of a project team, and identifying resources. Drawing on experience leading (more...)
Company: Sonepar USA
Location: Mount Vernon
Posted on: 03/5/2021

Walmart eCommerce - EH&S Operations Manager - NJ3
Description: Job Description: ul li Communicate with or to individuals or groups verbally and/or in writing e.g. customers, suppliers, associates . li Drive and implement the business plan for area of responsibility (more...)
Company: Walmart
Location: Vineland
Posted on: 03/5/2021

Life Enrichment Manager (Part-Time)
Description: Overview br Sunrise is the best place that I've ever worked, simply because of the people. We provide quality care in an environment that feels like home. Our focus is doing what's right for the resident. (more...)
Company: Sunrise Senior Living
Location: Wayne
Posted on: 03/5/2021

RN / Registered Nurse / New Jersey / Any / Travel RN Nurse Manager Job
Description: Specialty: RN-Neuro Intensive Critical Care-TravelLocations: El Paso, TexasShift: 7A to 7PDuration: 13 weeksStart Date: ASAPJob Description ul li Helps patients suffering from neurological problems
Company: All Medical Personnel
Location: New Brunswick
Posted on: 03/5/2021

Regional Sales Manager - Own a Franchise
Description: Own A Franchise br 40 BUSINESS CATEGORIES br PROVEN BUSINESS MODELS br FIND OUT HOW BUSINESS br OWNERS CAN EARN MORE br Have you ever thought about owning your own business If so, now is the (more...)
Company: WilliamsonHeckt
Location: Scranton
Posted on: 03/5/2021

Private Equity - Due Diligence - Vice President
Description: Role Objective iCapital is looking for a candidate to join its growing Research Due Diligence team. The candidate will focus on conducting due diligence on Private Capital funds and author thorough (more...)
Company: iCapital Network
Location: Greenwich
Posted on: 03/5/2021

Assistant Director/Associate Director - Market Access (REMOTE - MUST LIVE IN CENTRAL OR EASTERN[...]
Description: Assistant Director/Associate Director - Market Access REMOTE - MUST LIVE IN CENTRAL OR EASTERN TIME ZONE Type: Permanent br Experience: Experienced Professional Non-Manager br Education: Bachelor's (more...)
Company: MRINetwork
Location: Greenwich
Posted on: 03/5/2021

Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

New Brunswick RSS job feeds