[jsfg_cinti] Fw: Director, Global Regulatory Manufacturing - NJ

> >From ChemPharma
> > Director, Global Regulatory Manufacturing & GMP Quality Assuranc
> > Company:
> T.O.P.S.
> > Location:
> US-NJ-Englewood
> > Base Pay:
> N/A
> > Other:
> Full benefits, bonus
> > Employee Type:
> Full-Time Employee
> > Industry:
> Pharmaceutical
> >     Job Type:
> Manufacturing
> Pharmaceutical
> QA - Quality Control
>> Required Education:
> 4 Year Degree
> > Required Experience:
> More than 5 Years
> > Required Travel:
> Up to 25%
> > Relocation Covered:
> Yes
> >Description
> > Direct the Regulatory Manufacturing department in the preparation,
> submission and approval of NADAs/ANADAs/INADs/SNADAs for the company's
Division products globally. Coordinate and support VMF development by 3rd
party manufacturers globally. Ensure adequate regulatory support is provided
to the Manufacturing and Logistics Groups in the Division. Provides
leadership through establishing regulatory strategic direction and directing
execution of the department operational plan. Responsible for developing and
implementing global GMP Quality Programs and Policies. Responsible for
implementing a division wide GMP audit program to assure continuing internal
> and third party compliance with established standards. Represents the
> company to the FDA Center for Veterinary Medicine (CVM), state and local
regulatory agencies on manners pertaining to the manufacture of the
division's products.
>
> This is a direct, permanent hire position with our client company.
> Requirements
> Requires a Bachelor's degree in a scientific discipline and twelve years
> related experience (e.g. QA, Regulatory Affairs, Regulatory Compliance,
Mfg) in a pharmaceutical industry and a minimum of 5 years in Regulatory
affairs with strong GMP regulations and management experience. Expert
knowledge of GMPs, FDA Regulations. Current knowledge of applicable federal,
state and local regulatory requirements. Applied knowledge in the
preparation, submission and approval of Drug Applications. Strong strategic
thinking, critical reasoning, problem-solving and decision making skills.
Excellent oral and written communication skills.
>
> Contact us first! I act fast. We will get your information to the key
hiring manager immediately if your skill set is a match.
>
> Contact: Pamela Dunbar
> Vice President Sales & Recruiting
> Email: pdunbartops@xxxxxxxxxx
>
> Please email resume or CV in MS Word format as an attached document. Label
your email with the position title you are applying for. Unidentified email
from unknown sources is automatically deleted.

> Pamela Dunbar
> Vice President Sales & Recruiting
> T.O.P.S.
> Phone: 407-875-9900

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