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Global US Regulatory Strategist
US Tech Solutions Lawrenceville, NJ
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$74k-97k (estimate)
Full Time 1 Day Ago
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US Tech Solutions is Hiring a Global US Regulatory Strategist Near Lawrenceville, NJ

Duration: 12 months contract

Job Description:

· General Intercontinental markets regulatory requirements for drugs in development and/or registered.

· Understanding GRS tactical role, responsibilities, and deliverables to support drug development, commercial registration, and LCM of pipeline.

· Demonstrated ability to facilitate issue resolution and lead in a matrixed environment.

Responsibilities:

• Liaison between Country Regulatory Managers and Global Regulatory Teams/Development Teams/Brand Teams/Operating Committees

• Responsible in partnership with local GRS for generating, implementing and executing regulatory strategy and submission plans for development and life cycle products for the region

• Provides regional input into Global Regulatory Plan and Global Submission Plan

• Provides information and product knowledge to local regulatory

• Accountable for development of One Regulatory Voice for the region on project issues

• Represent the international markets on the GRST and serve as a core member to drive the strategy for these markets.

Experience:

• Demonstrated ability to break down complex, scientific content into logical components.

• Demonstrated ability to organize / prioritize tasks.

• Understanding of tactical role of GRS in the drug development process.

• Understanding of general global regulatory requirements for drugs in development.

• Understanding of PD&C process and specific GRS responsibilities / deliverables at PD&C Decision Points for International

Education:

· Solid scientific background, Ph.D., M.D., PharmD or equivalent professional experience with at least 5 years of experience in strategic regulatory activities supporting Intercontinental Markets (excluding US, EU, JP, CN, CA, UK, CH).

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Recruiter Details:

Name: Varshith

Email: varshith@ustechsolutionsinc.com

Internal Id: 24-14647

Job Summary

JOB TYPE

Full Time

SALARY

$74k-97k (estimate)

POST DATE

06/29/2024

EXPIRATION DATE

07/14/2024

WEBSITE

ustechsolutions.com

HEADQUARTERS

JERSEY CITY, NJ

SIZE

1,000 - 3,000

FOUNDED

1977

TYPE

Private

CEO

MANOJ AGARWAL

REVENUE

$200M - $500M

INDUSTRY

IT Outsourcing & Consulting

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