Thermo Fisher Scientific, a global leader in scientific research services, is seeking a talented Regulatory Affairs Specialist to join their remote team in India. This is a perfect opportunity for professionals with a background in regulatory science, especially M.Sc. graduates, to contribute to life-changing therapies and innovations. With a fully remote work setup, you can make a significant impact while working from the comfort of your home.
About Thermo Fisher Scientific: At Thermo Fisher, we are committed to enabling our customers to make the world healthier, cleaner, and safer. Our work spans across laboratory research, clinical trials, and regulatory affairs. The Regulatory Affairs team plays a critical role in accelerating product development and ensuring compliance with global regulations. If you are passionate about science and regulatory standards, this role could be a great fit for you.
Job Role: Regulatory Affairs Specialist
As a Regulatory Affairs Specialist at Thermo Fisher, you will be responsible for ensuring regulatory compliance across clinical trials and product development. Working within our PPD® clinical research portfolio, you will provide regulatory expertise and guidance to clients, assisting in the preparation of documentation, submissions, and project management. Location: Remote, India Job Type: Full-time Category: Clinical Research Work Schedule: Monday to Friday (Standard hours) Job ID: R-01285926Key Responsibilities:
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- Supports the preparation of documentation and submissions under guidance.
- Coordinates and manages client deliverables supporting regulatory compliance.
- Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects. Assists with project budgeting/forecasting.
- Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines.
- Assists in business development and pricing of projects for the department.
- Evaluates client needs in relationship to overall project timelines, quality and delivery.
- Engages other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed.
Knowledge, Skills, Abilities
- Good English language (written and oral) communication skills as well as local language where applicable
- Good attention to detail and quality as well as editorial/proofreading skills
- Good interpersonal skills to work effectively in a team environment
- Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
- Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
- Good negotiation skills
- Capable of working independently with direction and exercising independent judgment
- Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables
- Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management
- Basic understanding of medical terminology, statistical concepts, and guidelines
- Good analytical, investigative and problem-solving skills
- Capable of interpreting data
Work from Home Regulatory Affairs Specialist Hiring | Thermo Fisher[/caption]
Qualifications:
- Educational Background: Bachelor's degree or higher (preferably in life sciences or related fields such as M.Sc.).
- Experience: Minimum of 2 years of relevant experience in regulatory affairs, ideally within clinical research or pharmaceuticals.
Why Thermo Fisher?
Thermo Fisher offers an inclusive work culture that values diversity and empowers individuals to contribute their unique perspectives. This role is ideal for candidates looking to work remotely while contributing to a dynamic, innovative global team. You'll have the chance to engage in clinical research projects that positively impact patient outcomes and make a real difference in the world.How to Apply: Interested candidates can apply directly through the official Thermo Fisher career portal. Apply Here
https://pharmastuff.org.in/job/remote-regulatory-affairs-specialist-hiring-thermo-fisher
