...to think creatively, take initiatives, and drive innovative solutions.
We are looking for a Sr. Regulatory Affairs / Regulatory Intelligence Associate (Pharmaceutical and Medical Devices) specializing in Pharmaceuticals and Medical Devices supporting monitoring, analyzing...
...services. We are looking for an experienced individual in GDD Regulatory Affairs to lead the business analysis activities for the solutions... ...and Qualifications
• Bachelor's degree in engineering or pharmaceutical discipline.
• An advanced degree (MBA, MS etc.) and related...
...exploring candidates with a less traditional background.
Job Description
Job Summary
We are looking for a seasoned Head Regulatory Affairs to lead the regulatory strategy, ensuring compliance with health product regulations and fostering organizational growth through...
...launches; private equity fund administration; advisory firm set-up, regulatory registration and infrastructure design; ongoing regulatory... ...Responsibilities
The Senior Associate: Enterprise Risk and Regulatory Affairs will provide support:
to the attainment of the overall...
...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...
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...
Join the fastest growing Generic company specializing in Injectables, Oncology, Ophthalmic & hormones
Join our team as an Executive, Sr. Executive, Asst. Manager or Deputy Manager
Be a part of our success story!!!
We have openings for the following positions:
Exp...
...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...
...Job Description
W.R. Grace is hiring a Pharmaceutical Applications Specialist to Support the Materials Technologies business in various R&D projects by performing laboratory work in making and testing new materials for pharmaceutical applications. This job is based out...
...affecting optimal and timely submission. Independently manage US regulatory compliance activities, including timely review and updates to... ...we serve.
Role Requirements
• Minimum of 3 years pharmaceutical experience with a minimum of 1-2 years of regulatory experience...
...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,...
...under limited supervision to provide strategic and operational regulatory direction and may support the DRA global program team (GPT)... ..., PharmD, regulatory) preferred
• Advanced understanding of pharmaceutical development, clinical trials, analysis and interpretation of scientific...
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 within Corporate Finance. The Regulatory Assurance team is responsible for the independent verification of controls and processes over...
...ideal individual for this role should exhibit exceptional leadership skills and possess a vision for creating an innovative discovery pharmaceutics support team working closely with pharmacokinetic, chemistry, tox, and pharmacology colleagues. The role includes using...
...Your responsibilities include but not are limited to:
• Regulatory Strategy -Responsible for implementing regulatory strategy and... ...a global/matrix environment or cross- functional teams in the pharmaceutical industry
• Experience in HA negotiations. Experience or project...
...clients operating worldwide.
Job Description
Responsibilities (how we will measure success)
To provide support for the Group’s Regulatory horizon scanning strategy and arrangements throughout the business.
The role holder will be responsible for working with the...
...About the role
Position Title: Senior Regulatory Writer
About the role: Senior Regulatory Writer
Location – Hyderabad #LI Hybrid
That is the approximate number of individual regulatory documents the dynamic team at Regulatory Writing and Submissions (RWS) planned...
...Senior Manager - Regulatory Reporting CTB - BFS028692
With a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it. We dream in digital, dare in reality, and reinvent the ways companies...
...with Finance, Business Development, Research & Development, Regulatory Affairs, Quality Assurance, Lab Operations, Marketing, Sales and Supply... ...other related discipline
~5+ years of experience in the pharmaceutical industry
~2+ years of project management experience
~...
...Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians... ...from Statistics, Legal, Regulatory Affairs, Data Privacy, Data Management and Clinical... ...equivalent with 4 years experience in the pharmaceutical industry and broad understanding of the...
...with Company, international standards and regulatory requirements, as assigned.
Key... ...received from Global & Local Regulatory Affairs and PV departments) within respect of timelines... ...Aggregate Report Reviews
~10 Years of pharmaceutical industry experience, preferably working...
...inputs into responses to inquiries from regulatory authorities or health care professionals... ...colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information,... ...4 years in drug development in a major pharmaceutical company, including 2 years in patient...
...Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus... ...functional teams, like R&D, manufacturing, SCM, quality assurance, regulatory affairs, and others.
• Strong analytical and problem-solving...
...development. Includes the regular update of pharmaceutical and medical assessments (e.g. regarding... ..., and to use in discussions with regulatory authorities as necessary (e.g. Scientific... ...Global Portfolio Management; Regulatory Affairs); BD&L, Global Portfolio Management, Commercial...
...topic/key messages, language and grammar are accurate, regulatory/safety/legal aspects are considered.
• Provide... ...experience in Medical Information/Communications in the Pharmaceutical Industry (or related Medical Affairs role).
• Knowledge and application of good practices...
...manufacturing processes across the industrial affair sites. Allow new generation of... ...Manufacturing Processes in industrial plants within pharmaceutical context (GXP regulations)
Core... ....
Knowledge of Pharma industry regulatory best practices applied to Digital development...
...compliance (considering internal and external/regulatory requirements).
• Exhibit leadership... .../or Process ownership experience in a pharmaceutical or healthcare consulting setting,... ...Pharmacovigilance), clinical research, or regulatory affairs (incl. appropriate business case...
...Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees... ...key thought leaders. Oversee the execution of the medical affairs plan, facilitate the flow of medical developments to the sales...
...for contributing to the planning, coordination, development and timely delivery of high quality Clinical submission documents to Regulatory Affairs (RA) for
New Drug Applications (NDA) , Biologic Licensing Applications (BLA), Marketing Authorization Applications (MAA)...