- Experience with CMC regulatory documents (global registrations, including NDAs, MAAs and others, responses and supplements/variations)
- Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations
- Experience in post-approval requirements
- Experience in developing CMC regulatory strategy
- Experience in project management
- Have a solution-oriented approach to problem solving
- Ability to plan/prioritize work of group members and guide/develop others.
- Ability to work on complex projects and within cross-functional teams with supervision
- Excellent communication skills, both written and oral
- Excellent computer skills.
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Senior Risk Manager
6 days ago
Evonik Group. Piscataway, United StatesWat we bieden · Ontdek samen met ons een wereld aan mogelijkheden. Kijk samen met ons vooruit en geef vorm aan innovatieve oplossingen om onze wereld duurzamer te maken en het leven gezonder, levendiger en comfortabeler te maken. Bij Evonik krijgt u de kans om u samen met meer da ...
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Senior Manager
3 days ago
Bristol-Myers Squibb New Brunswick, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...
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Senior Tax Manager
1 week ago
Johnson & Johnson New Brunswick, United StatesJohnson & Johnson is recruiting for a Senior Manager, International Taxation. The position is located in New Brunswick, NJ. · At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are preve ...
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Multi Asset Portfolio Manager
1 day ago
New Jersey Community Capital New Brunswick, United States**_New Jersey Community Capital is a nonprofit community development financial institution that provides an innovative toolkit of financial products, programs, and services to advance equity and opportunity in the communities we serve. _** · **Multi Asset Portfolio Manager** · Lo ...
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Director Portfolio Program Management
1 week ago
Johnson & Johnson New Brunswick, United States**Johnson & Johnson is recruiting for a Director, Portfolio Program Management, located in New Brunswick, NJ.** · This individual will be responsible for shaping and leading a comprehensive Finance Technology Project Portfolio approach that will direct and coordinate all aspects ...
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Internal Audit Manager
1 week ago
PGX, LLC East Brunswick, United States**About the Firm**: · PGX, LLC is a professional services firm serving the many needs of leading consulting firms that provide risk management services including outsourced internal audit needs of community banks and credit unions. Over the years, we have become a leading provide ...
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Assistant Vice President, Logistics
1 week ago
RWJBarnabas Health New Brunswick, United States**Job Overview**: · The AVP of Logistics is responsible for the leadership and function of the departments for overall qualify of care delivered theought the hospital organization. This leader will oversee the development, implementation and oversight of efforts, planning, organi ...
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Executive Assistant
1 week ago
Rutgers University New Brunswick, United States**Position Details**: · - Position Information**Recruitment/Posting Title** · - Executive Assistant**Job Category** · - Staff & Executive - Administrative & Support**Department** · - RWJ-Anesthesiology-Meb**Overview** · - New Jersey's academic health center, Rutgers Biomedical an ...
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Internal Auditor
6 days ago
PGX, LLC East Brunswick, United States**Description**: · PGX, LLC is a professional services firm serving the many needs of leading consulting firms that provide risk management services including outsourced internal audit needs of community banks and credit unions. Over the years, we have become a leading provider o ...
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Keyboarding Clerk 1
1 day ago
Middlesex County North Brunswick, United StatesOverview: · Under close supervision, performs routine, repetitive clerical work involving the processing of documents in a variety of functions; formats and key enters/types correspondence, documents, reports, charts and other materials on a computer console, typewriter, or other ...
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Spd Coordinator
3 days ago
Saint Peter's Healthcare System New Brunswick, United StatesResponsible for coordinating the complete case cart cycle for the purpose of maintaining a smooth functioning process. Collaborates with Manager of SPD in evaluating the needs of SPD staff involved with the case cart system. · - Ability to interpret and understand charts and gaug ...
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Utilities Supervisor
1 day ago
Rutgers University New Brunswick, United States**Position Details**: · - Position Information**Recruitment/Posting Title** · - Utilities Supervisor**Job Category** · - Staff & Executive - Facilities/Environmental/Maintenance**Department** · - IPO-Facilities Utilities**Overview** · - The Division of Institutional Planning & Op ...
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Dietary Aide
1 week ago
Mira Vie East Brunswick, United States**Welcome to **Distinctive Living** **We're seeking a **Dietary Aide** _(_Part-Time_)_ _for our Senior Living community Mira Vie at East Brunswick · Here at _Distinctive Living_, we want our people to realize their full potential. We're passionate about personal and professional ...
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Associate
6 days ago
Newmark East Brunswick, United States**Job Summary**: · In partnership with and/or under the guidance of a Senior Broker, the Associate Broker is tasked with management of accounts, prospecting, business development, securing engagements, and staying informed of trends and developments in real estate. · **Skills, Ed ...
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Vice Dean of Administration
3 days ago
Rutgers University New Brunswick, United States**Position Details**: · - Position Information**Recruitment/Posting Title** · - Vice Dean of Administration**Job Category** · - Staff & Executive - Finance/Accounting/Purchasing**Department** · - SAS - Dean's Office**Overview** · - The School of Arts and Sciences (SAS) is the lar ...
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Project Coordinator
6 days ago
Bristol-Myers Squibb New Brunswick, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...
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Project Coordinator
6 days ago
Bristol-Myers Squibb New Brunswick, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...
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Commercial Lender
1 day ago
The First Bank Brunswick, United States**Job Summary**: · Manages and develops consumer loan accounts, which meet the established lending requirements while maximizing profitability and minimizing risk to the bank. Contributes to the growth and profitability of the bank through consumer and residential loans. They mus ...
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Director of Insights
5 days ago
Johnson & Johnson New Brunswick, United StatesJohnson & Johnson is recruiting for a Director of Insights. · At Engineering & Property Services (E&PS) we take care of all J&J buildings around the world, providing end-to-end services from Real Estate, Engineering & Strategic Project Delivery to Facilities Management. We have a ...
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General Dynamics - Bath Iron Works Brunswick, United States**Job Description**: · This position will support a wide range of Quality Assurance and Applications tasking as they specifically relate to the Life Cycle Services contract(s). Assignments may require travel to Life Cycle Homeport offices. This position is located at the Surface ...
CMC Senior Manager - New Brunswick, United States - Sunrise Systems Inc
Description
PREREQUISITES
BS/BA degree in Scientific Discipline (master's or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience
Skills/Knowledge Required: