Job Post: Senior Analyst, Regulatory Intelligence – India
Location: Bangalore / Gurgaon, India
Job Type:Full-Time
Overview of Role:
We are looking for a skilled Senior Analyst, Regulatory Intelligence to join our India office. The successful candidate will create and maintain high-quality regulatory intelligence content focused on clinical trial data.
Responsibilities:
- Prepare, review, and update regulatory documents for clinical trials, focusing on the US and Canada.
- Collaborate with cross-functional teams and regulatory experts to ensure accurate and timely regulatory intelligence.
- Perform quality control of external expert contributions related to clinical trials.
- Provide clinical trial knowledge to support inquiries from customers, sales, marketing, and business development.
- Act as a subject matter expert in regulatory knowledge for clinical trials.
- Manage workload and deliverables effectively.
- Provide guidance and feedback to colleagues and assist in their training and development.
- Conduct and present regulatory training sessions for small groups or individuals within the team.
Required Knowledge, Skills, and Abilities:
- Proven experience in clinical trials within life sciences, particularly in the APAC region, US, and Canada.
- Hands-on experience in clinical trial submissions in the APAC region, US, and Canada is preferred.
- Degree in life sciences with additional education in clinical trials is advantageous.
- In-depth knowledge of clinical trial regulations, including drug development phases, regulatory applications, approval processes, and registries.
- Ability to understand, interpret, and communicate regulatory developments and trends.
- Prior knowledge in biologics is a plus.
- At least 4-5 years of relevant experience.
- Strong communication skills (verbal and written) and experience writing summaries/reports.
- Attention to detail, proactive, and highly organized.
- Knowledge of quality management within life sciences.
- Strong software and computer skills, including Microsoft Office and publishing tools.
- Self-motivated and enthusiastic.
- Ability to manage multiple projects and follow standard operating procedures consistently.
- Ability to adapt quickly to a rapidly changing environment.
Physical & Mental Requirements:
- Must be able to sit for long periods.
- Frequently required to stand, walk, sit, talk, and hear.
- Occasionally climb stairs and/or ride elevators.
- Occasionally lift and/or move up to 25 pounds.
- Able to manipulate keyboard, operate a telephone, and hand-held devices.
- Able to maintain focus and attention to detail in a fast-paced environment.
- Accenture is looking for Pharmacovigilance Associates. B.Pharm/BSc graduates can apply.
- Azurity Pharmaceuticals is hiring a Drug Safety Associate in Hyderabad, Telangana.
About IQVIA:
IQVIA, formerly known as Quintiles and IMS Health, Inc., is an American multinational company that provides advanced analytics, technology solutions, and clinical research services to the life sciences industry. As a Fortune 500 and S&P 500 company, IQVIA is dedicated to using data and scientific insights to help healthcare clients find better solutions for their patients. With over 88,000 employees in more than 100 countries, IQVIA leverages its vast network and expertise to support the development of innovative therapies and improve patient outcomes.
IQVIA focuses on biopharmaceutical development, clinical trials, and laboratory services, offering a comprehensive suite of services from Phase I to Phase IV clinical trials. The company’s commitment to innovation and excellence is evident in its robust pipeline and the high-quality solutions it provides to clients.
IQVIA believes in pushing the boundaries of human science and data science to make a significant impact on global health. By combining cutting-edge technology with human expertise, IQVIA strives to create a healthier world for all.
Learn more at: IQVIA Careers
Disclaimer: We strongly advise against paying any third-party individuals or agencies who claim to offer job placements at our company. All job openings are filled based on merit through our official hiring channels. Protect yourself from fraud and ensure that your application is processed securely and fairly by only engaging directly with our official representatives.
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