Search Results: 6,797 vacancies
Responsibilities
Prepare applications for the permits, licenses, certificates, authorizations, and other approvals that the organization needs to conduct its business activities; and produce, sell, and distribute its goods and services. These may include product licenses...
...This inclusive employer is a member of myGwork – the largest global platform for the LGBTQ+ business community.
Regulatory Affairs Labeling
Bachelor's Degree plus at least 5 to 8 years of experience in drug development especially in labeling, product package coordination...
...fund administration; advisory firm set-up, regulatory registration and infrastructure design;... ...: Enterprise Risk and Regulatory Affairs will provide support:
to the attainment... ...We also offer opportunities across our service lines and our international network of offices.
...services. We are looking for an experienced individual in GDD Regulatory Affairs to lead the business analysis activities for the solutions... ...demonstrated etc.) are on track.
• Liaise with vendor, Novartis internal IT teams and business to ensure documentation is at the...
...Description
Job Summary
We are looking for a seasoned Head Regulatory Affairs to lead the regulatory strategy, ensuring compliance with... ...complex data clearly
Able to manage cross-functional internal and external stakeholders and manage cross cultural nuances...
...the development and implementing the effectiveness of the robust regulatory strategy and plans for
projects in development and approved,... ...guidance, requirements, and strategy for assigned projects to internal
and external stakeholders, ensuring compliance with...
...Position Overview:
The Manager of regulatory and Strategic Development will be responsible... ...development submission management and regulatory affairs programs.
Develop and execute on... ...and direct crossfunctional teams of internal and external personnel to deliver client...
...Regulatory CMC, Regulatory Delivery Excellence leads, in partnership with the GRA-CMC RA Scientists, the various aspects of global marketing... ...maintenance of products
Strong working knowledge of internal procedures, guidance, and regulatory precedence
Will triage...
...- CTD Dossier Drafting (Modules 2, 3, 4)
- Regulatory writing
- Clinical Regulatory Pharmacovigilance Regulatory
- Preparation of Tox applications, CTAs, MAAs
- Regulatory commitment compliance
- Any other Regulatory activities on need basis
- Support Line...
About the Role
Role Title: Sr. Spec. DDIT Dev. Technical Design (Regulatory Affairs)
Location: Hyderabad
Role Purpose:
The purpose of the role is to
• Lead the design and managing deliverables of RA Publishing business critical applications as well as provide support...
...electronically or paper) and distribution of regulatory submission and clinical trial dossiers,... ...regulatory dossiers for regulatory affairs category teams, either for direct submission... .../ reports / documents in compliance with internal and external publishing quality standards...
...The purpose of this role is to manage the regulatory information management (RIM) system for... ...ensure key information is provided to meet internal/external compliance databases (e g EU Art... ...organisation, in particular Regulatory Affairs.
Understanding of global regulatory affairs...
...Department : Regulatory Affairs, US Market
Role : Labeling
Experience : 2-8 years
Qualification : B. Pharm/M. Pharm
Job Description
- Review, Finalization and Compilation of Module-1 Documents for the filing of ANDAs and NDA.
- Amendments (Labeling / Gratuitous...
...affecting optimal and timely submission. Independently manage US regulatory compliance activities, including timely review and updates to... ...Network here:
Division
Development
Business Unit
REG AFFAIRS GDD
Work Location
Hyderabad, AP
Company/Legal Entity...
...off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.
Summary:
The Senior Regulatory Specialist is the subject matter expert and leader of a regulatory team to prepare and maintain complete and accurate regulatory documents...
...Department : Regulatory Affairs, US Market
Role : Post Approval
Experience : 2-8 years
Qualification : B. Pharm/M. Pharm
Job Description :
- Planning, reviewing and submission for assigned ANDA and NDA projects within timelines.
- Adherence to high quality,...
...information into intelligence, inspiring the world to learn, communicate and advance faster than ever.
JR51354 Government and Public Affairs Manager
Job Description for Government and Public Affairs Manager
Micron Technology's vision is to transform how the world...
...Role Description
This is a full-time on-site role for a Director Academic Affairs (Social Sciences) at Woxsen University located in Hyderabad. The Director Academic Affairs will be responsible for overseeing the academic programs and faculty within the Social Sciences...
1.Prepares, literature review, abstracts, posters, and slide sets, and Manuscripts (complex) working from various data sources including clinical study reports, patient profiles, protocols etc. 2. Performs quality control (QC) checking / proof reading of the above mentioned...
...Basic Purpose of Job: The Regulatory Reporting Assurance (RRA) department is a management assurance team in the Controller’s Organization... ...assurance function
Execute a framework to test if the internal systems supporting compliance with regulatory requirements and...
