Search Results: 3,532 vacancies
Company Description
ArtiXio is a regulatory and commercial consulting company located in Hyderabad. We provide support to pharmaceutical, cosmetics... ..., and dietary supplement manufacturers with global regulatory affairs and product commercialization. Our services include primary and...
...the development and implementing the effectiveness of the robust regulatory strategy and plans for
projects in development and approved,... ...procedures and changes.
Coach and develop regulatory associates. Support a culture of high performance and trust, assure that the...
...services
We are looking for an experienced individual in GDD Regulatory Affairs to lead the business analysis activities for the solutions... ...advantage
Key Responsibilities:
Engage with global business associates and leverage the appropriate teams and functions to determine...
...Preparing the NDA submission for Emerging Markets, communicating with regulatory agencies, and managing the regulatory review process. Ensuring... ...regulatory review and approval.
Work with a team of regulatory affairs experts of various countries to ensure that the NDA is submitted...
...implement the effectiveness of the robust regulatory strategy and approach for assigned... ...Responsibilities
Represent Regulatory Affairs and assist with regulatory activities for... ...agencies.
Establish and manage timelines associated with regulatory submissions in alignment...
...Regulatory CMC, Regulatory Delivery Excellence leads, in partnership with the GRA-CMC RA Scientists, the various aspects of global marketing authorization submission management processes
Partners with GRA-CMC Scientists to help create and manage Leo/Regulus submission...
...- 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...
...Position Overview:
The Manager of regulatory and Strategic Development will be responsible for developing and implementing and regulatory... ...strategic development submission management and regulatory affairs programs.
Develop and execute on global strategic plans (regulatory...
...the Role
Role Title: Sr. Spec. DDIT Dev. Technical Design (Regulatory Affairs)
Location: Hyderabad
Role Purpose:
The purpose of the... ...world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this...
...needed to thrive in our organization.
Role And Responsibilities
Role: Planning, preparation, compilation, and publishing of regulatory submissions electronically to the FDA as per the project submission goal date, ensuring continued regulatory compliance.
Key Accountabilities...
...The Associate Project Manager will set and develop the operational aspects of the project, develop, and monitor timelines, milestones and project metrics and is responsible for managing the Reach-Cost-Quality (RCQ) metrics from an operational perspective from the development...
...communication global or local teams, Medical regulatory writing global or local teams,... ...Pharmacovigilance teams, Regulatory Teams and Corporate Affairs Teams based on the documents assigned.... ...of the medical regulatory plan and associated activities for the year identified for...
...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...
...Regualtory Specialist I prepares and maintains complete and accurate regulatory documents in support of clinical research studies.
Role &... ...year of relevant experience in the life science industry OR
Associate’s degree with 2 years of relevant experience in the life...
...activities
Proactively identify issues, gaps, and trade-offs affecting optimal and timely submission
Independently manage US regulatory compliance activities, including timely review and updates to product specific information as provided by program team representative...
...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,...
...The CMC Regulatory Lead will oversee the CMC regulatory activities for innovation projects and CMC maintenance within the CHC portfolio, as per assignment.
Main Responsibilities:
Represent GRA CMC CHC in Global cross-funtional teams and meetings, partners with the leaders...
BALAXI PHARMACEUTICALS LIMITED is looking for Regulatory Executive to join our dynamic team and embark on a rewarding career journey
Staying up-to-date with the latest safety and regulatory requirements and industry best practices
Analyzing and interpreting regulatory...
...with the CLP Regulation.• Perform, interpret, and communicate EU regulatory impact assessments for all business units. • Help manage all... ...related questions.• Any other Product stewardship and regulatory affairs related tasks that may be assigned.• Expected to have a general...
...Position Title - Manager External Affairs Location - Golconda, Hyderabad
Experience - 8-15 years of work experience in Liaising
Regulatory Compliance
Stay up to date with local, state, and national regulations related to alcohol production, distribution, and marketing...