Job Details
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: ...@ustechsolutionsinc.com
Internal Id: 24-14647