...a highly motivated individual to join the Product Steward & Regulatory Affairs (PSRA) team. The Product Steward Representative is the key link... ...Product Stewardship & Regulatory Affairs colleagues, Trade Associations and/or NGOs.
• Project leadership: Develop AP regional...
RA US injectable JD:
Knowledge on manufacture and testing of sterile products and Knowledge of environmental conditions during sterile product manufacturing.
Review and clearance of pre-exhibit batch R&D documents like formula clearance w.r.t Q1/Q2, IIG, specifications...
...private equity fund administration; advisory firm set-up, regulatory registration and infrastructure design; ongoing... ...Job Description
Responsibilities
The Senior Associate: Enterprise Risk and Regulatory Affairs will provide support:
to the attainment of the overall...
Hetero Walk In Interview A Leading USFDA approved Pharmaceutical Company, looking for the candidates for Professional - Regulatory Affairs Area of Work: ROW, US, EU & Emerging Market
Qualification: B.Pharm/ M.Pharma/ M.Sc. Industry: Pharmaceuticals Experience: 2-8 years experience...
· Should have experience in Regulatory Affairs pre & post approvals (Life cycle management). · 9-12 yrs of experience in Pharmaceutical industry.
...About the role
Role Title: IT Business Analyst - Regulatory Affairs
Location: Hyderabad
About the Role:
The job purpose is to act... ...advantage.
Key Responsibilities:
• Engage with global business associates and leverage the appropriate teams and functions to determine...
...About the job
The Regulatory Innovation Associate plays a critical role in the development of regulatory services technology products to drive innovation and differentiation.
Under general supervision, provides regulatory expertise and technical support for 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...
...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...
...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,...
...and an annual incentive program.
Summary:
The Senior Regulatory Specialist is the subject matter expert and leader of a regulatory... ...and 4 years of clinical research regulatory experience OR
Associate’s degree with 6 years of clinical research regulatory experience...
...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 department...
Woxsen University
Hyderabad
2 days ago
...Role Description
This is a full-time on-site role for a Director Academic Affairs - Social Sciences at Woxsen University located in Hyderabad. As the Director of Academic Affairs, you will be responsible for overseeing academic programs and ensuring their quality and compliance...
Woxsen University
Hyderabad
4 days ago
...About the role
Position Title: Senior Regulatory Writer
About the role: Senior Regulatory Writer
Location – Hyderabad #LI Hybrid... ...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...
Role Description
This is a full-time on-site role for a Director of Academic Affairs (Social Sciences) at Woxsen University located in Hyderabad. The Director of Academic Affairs will be responsible for overseeing the academic programs in the Social Sciences department, ensuring...
Woxsen University
Hyderabad
2 days ago
...related 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...
Job Title: Vice President of Academic Affairs - Technology-Integrated Curriculum Development
Job Overview
The Vice President of Academic... ...and private training programs meet industry standards and regulatory requirements.
• Contribute to the development of long-term strategic...
American International University, Kuwait
Hyderabad
2 days ago
About the Role
Location: Hyderabad
Role: Associate Director, GDD Data Team
Function & Responsibilities: Development Data Team... ..., Clinical Data Standards, Technical Research & Development, Regulatory Affairs and Patient Safety. Function also collaborates with cross...
...looking for seasoned Project Manager, who has experience with regulatory reporting and excellent financial industry knowledge. Should demonstrate... ...substitute for education).
~ Working knowledge of Axiom and associated data models and requirements is required
~ Exposure to...
...role
Your responsibilities include but not are limited to:
• Regulatory Strategy -Responsible for implementing regulatory strategy and... ..., review performance and plan compensation), develops associates (development/training plans, Organizational Talent Review, coaching...
...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...
...within the accounts payable function.
Adhere to financial policies, procedures, and internal controls (SOX) to ensure compliance with regulatory requirements.
Maintain regular updates to the invoice processing documentation (SOP).
Requirements:
Minimum 4 years of...
Hyderabad
6 days ago
...Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians... ...from Statistics, Legal, Regulatory Affairs, Data Privacy, Data Management and Clinical... ...understanding of the driving forces and their associated perspectives.
• Strong, detailed...
...across all facilities.
· Develop and implement production strategies to meet quality, quantity, and cost targets, while adhering to regulatory and compliance standards.
· Drive continuous improvement initiatives to enhance productivity, reduce waste, and optimize resource...
$ 9600 p.a.
...demonstrating thorough understanding of the client's requirements and business.
Demonstrating professionalism by working within legal and regulatory guidelines while remaining independent and objective at all times.
Drafting Appeals for review by Partner/principal & attend...
...are seeking a highly motivated and experienced Clinical Research Associate (CRA) with a minimum of 2-3 years of relevant experience. The... ...will have a strong understanding of clinical trial processes, regulatory requirements, and excellent communication and organizational skills...
...Manage activities associated with the preparation of non-oncology Investigator Brochure (IB) annual updates within Biomedical Research (... ...Quality Management (DQM) team and other key stakeholders e.g. Regulatory Operations to ensure strategic resource planning of downstream...
...incomplete data including, but not limited to, staying current with regulatory initiatives, new financing techniques used by the marketplace... ..., and presentations for leadership teams.
Mentor junior associates; provide guidance; serve as subject matter experts.
Knowledge...
...Associate Clinical Data Manager
SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting... ...that are required at SDC to maintain compliance to business and regulatory requirements
• Track and maintain audit-ready clinical study...
...Collaborative and supportive work environment.
The Role
Job Summary:
We are seeking a dynamic and enthusiastic Marketing Associate to join our team at INAORB PRIVATE LIMITED. The ideal candidate will play a pivotal role in promoting our company services and expanding...